The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

This includes:

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).

Roles & Responsibilties

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

JOBSCOPE OVERVIEW

1. Represent QA/QC department in 2G Management Meetings or other meetings required by Directors.

2. Create and maintain standard operating procedure (SOP’s), protocols, guidelines that ensure consistency and efficiency throughout the QA cycle.

3. Acts as Committee of all ISO audits.

4. Supervise and manage QA/QC team and interns.

5. Conduct physico-chemical and microbiological test for Chemicals and Incoming Paper.

6. Liaise with suppliers and third-party agencies.

7. Provide technical support to the sales and marketing team regarding product specifications, sample requirement & others.

8. Document those methods in standard operating procedures (SOPs) and production records, quality assurance activities with internal reporting and audits.

9. Review and compile documents for Audits (Batch Record: Prod sheet, Quality control test Reports; FG and RM Reports, Mixing records).

10. Ensure that on time calibration program of equipment (mechanical and lab instruments, weighing scales and test weights) are executed.

11. Assist to do in compounding and mixing when Mixer Operator is on leave.

12. Liaise with Overseas factory (China and Indonesia) to ensure that product or service meets specified requirements.

13. Review method validation study reports, ensure proper documentation of findings, and assist in approval or re-validation recommendations. Prepare summary reports of validation activities, results, and recommendations for management review.

14. Investigate validation failures or deviations, identify CAPA, and ensure implementation. Collaborate with cross-functional teams to enhance the efficiency and effectiveness of validation activities.

15. Identify risks in testing methods, implement mitigation strategies, and ensure data integrity during validation to maintain accuracy, reproducibility, and regulatory compliance.

16. Review and approve method validation documentation, ensuring accuracy, completeness, and compliance with quality standards. Maintain up-to-date records of validation activities, deviations, CAPA, and ensure proper version control for all related documents.

17. Provide training on method validation processes and best practices, and support Production, QC and R&D teams in executing protocols and analyzing data accurately.

18. Any other area of responsibilities that the company deems necessary.

A. QUALITY CONTROL

1. Manage product complaints or non-conformances; thoroughly investigate process failure, determine the root cause, and take prompt corrective actions.

2. Conduct physical, physico-chemical test and microbial analysis of finished product.

3. Track the materials (chemicals and fragrance) that are present in the chemical room and know whether additional supplies need to be ordered.

4. Calibrate all equipment for In-house verification Example – pH meter, weighing scale etc. and arrange external calibration with external party.

5. Train new production operators in quality control.

6. Any other area of responsibilities that the company deems necessary.

B. LIAISE WITH SUPPLIERS (Services):

1. DI Water System Maintenance (Requirements: According to Contract): Loop Sterilization, UV-Lamp etc.

2. Complete Water Quality Testing (annual) by External Lab

3. Monitor the consumable supplies from different suppliers for DI Water (Column, filters, gauges).

4. Wet Wipes Monthly External Microbial testing

5. Monitor the annual cleanroom Certification.

6. External Calibration of Equipment

7. Any other area of responsibilities that the company deems necessary.

C. PRODUCT TECHNICAL SUPPORT

1. Support Export Sales and Marketing for preparation of documentation for regulatory use (COA, Ingredient’s list, FG and RM spec etc).

2. Collaborate with development, QC, and regulatory teams to plan, execute, and review method validation protocols, ensuring compliance with applicable guidelines (e.g., ICH, FDA, EMA) and company procedures, while meeting regulatory standards for intended use.

3. Support on the process validation on the manufacturing of the product.

4. Any other area of responsibilities that the company deems necessary.

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

Key Responsibilities

Functional and Automation testing experience including tools such as Selenium, UFT, JIRA, Postman

• Degree in software engineering, computer engineering, electrical engineering or infocomm-related discipline

• Must have professional software quality testing experience with hands-on automation

• Strong understanding of testing techniques, risk analysis

• Strong understanding of test-driven development, continuous integration and continuous delivery

• Experience with automation scripting (i.e. Python and shell scripts)

• Experience with open-source automated testing frameworks (i.e. RobotFramework, Selenium Webdriver)

• Experience with open-source performance testing tools (i.e. JMeter, Gatling, Locust) or enterprise level testing tools (HP LoadRunner)

• Experience with open-source penetration testing tools (ZAP, Burp Suite, SQL Map) or enterprise level penetration testing tools (HP WebInspect, Nessus, CheckMarx)

• Working experience in Agile environment will be an added advantage

• Excellent verbal communication and listening skills

• Proactive, self-driven and motivated

Position Overview: We are seeking a dedicated and detail-oriented Quality Engineer to join our team. The successful candidate will be responsible for ensuring the quality of low voltage switchboard panels to meet industry standards and client requirements. This role requires a strong understanding of electrical systems, testing procedures, and quality assurance.

Key Responsibilities:

• Conduct comprehensive testing of low voltage switchboard panels, including insulation resistance tests, contact resistance tests, high voltage tests and function tests.
• Perform inspections and audits of electromechanical assemblies to ensure compliance with applicable standards and specifications.
• Document test results and prepare detailed reports for internal and client review.
• Collaborate with design and manufacturing teams to identify and resolve any issues or discrepancies.
• Ensure all testing equipment is calibrated and maintained in good working condition.
• Participate in continuous improvement initiatives to enhance testing processes and procedures.
• Train production staff on quality control processes and provide guidance on quality-related matters.
• Stay updated with industry standards and advancements in testing methodologies.
• Ensure the quality of products meets the required standards and specifications.
• Support onsite testing, FAT, SAT and troubleshooting activities, if necessary.

Qualifications:

• Minimum Diploma in Electrical Engineering or a related field.
• Minimum of 2 years of experience in testing low voltage switchboard panels or similar electrical equipment.
• Strong knowledge of electrical testing procedures and standards (e.g., IEC 61439).
• Proficiency in using testing equipment and tools.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and accuracy.
• Good communication and teamwork skills.
• Ability to work independently and manage multiple tasks effectively.

Preferred Qualifications:

Certification in electrical testing or quality control.

Key Responsibilities

Functional and Automation testing experience including tools such as Selenium, UFT, JIRA, Postman
• Degree in software engineering, computer engineering, electrical engineering or infocomm-related discipline
• Must have professional software quality testing experience with hands-on automation
• Strong understanding of testing techniques, risk analysis
• Strong understanding of test-driven development, continuous integration and continuous delivery
• Experience with automation scripting (i.e. Python and shell scripts)
• Experience with open-source automated testing frameworks (i.e. RobotFramework, Selenium Webdriver)
• Experience with open-source performance testing tools (i.e. JMeter, Gatling, Locust) or enterprise level testing tools (HP LoadRunner)
• Experience with open-source penetration testing tools (ZAP, Burp Suite, SQL Map) or enterprise level penetration testing tools (HP WebInspect, Nessus, CheckMarx)
• Working experience in Agile environment will be an added advantage
• Excellent verbal communication and listening skills
• Proactive, self-driven and motivated

Our company is looking for a Quality Assurance / Management Representative who will perform the following tasks:

• Manage the company's ISO9001:2015 and ISO45001:2018 systems by leading both internal and external audits.
• Monitor and analyze the company's quality and safety performance through the action plans in place.
• Keep abreast of the government requirements as well updates on the standards to ensure compliance of the company's systems and policies.
• Ensure that all statutory licenses, certificates, and inspections of the company's equipment and machinery are valid and up to date.
• Manage and monitor the company's measuring equipment and devices to ensure that they are calibrated as per the required standard of the products.
• Liaise with all external stakeholders such as government bodies (MOM, BCA, SCDF, etc) with regards to company's operation and compliance.
• Communicate with existing customers on their regular audits, non disclosure agreements, and additional requirements which may affect the company's status of being an approved vendor.
• Assist project engineers in securing Certificate of Origin (COO) and / or Preferential Certificate of Origin (PCO) for products.
• Analyze the applicable tariff to be applied for free trade agreement (FTA) purposes.

Main duties and responsibilities :

1. Incoming QA(IQA) and Outgoing QA (OQA) Inspection
2. Quality Wall (QW) buy off
3. Weekly process audit
4. Non Conformance Material Report (NCMR)

Experience and knowledge :

1. Min "O” level with 3 years of related experiences in a manufacturing environment.
2. Knowledge of Microsoft (words, excel and ppt) is a must.
3. Knowledge of Stamping, Plating, Molding and Connector Assembly is an added essential.

Skill Required :

1. Good knowledge on measurement methodology and equipment (profile projector, TM scope, OGP smart scope).
2. Exposure in Process and QMS Audit.
3. Knowledge of Quality tools such as SPC and 7 QC tools.
4. Good interpretation of product drawing, specification and Inspection Plan.

Job Requirement :

1. Able to work independently
2. Able to work rotation shift

Activate Interactive Pte Ltd (“Activate”) is a leading technology consultancy headquartered in Singapore with a presence in Malaysia and Indonesia. Our clients are empowered with quality, cost-effective, and impactful end-to-end application development, like mobile and web applications, and cloud technology that remove technology roadblocks and increase their business efficiency.

We believe in positively impacting the lives of people around us and the environment we live in through the use of technology. Hence, we are committed to providing a conducive environment for all employees to realise their full potential, who in turn have the opportunity to continuously drive innovation.

We are searching for our next team members to join our growing team.

If you love the idea of being part of a growing company with exciting prospects in mobile and web technologies that create positive impact on people’s lives, then we would love to hear from you.

What will you do?

• We aim to drive the adoption of modern software delivery at government agencies in order to better serve the needs and expectations of Singaporeans.
• As part of this endeavor, we are inviting interested applicants who are passionate about change and transformation to join us as Quality Engineer and to take on the exciting and challenging roles of accelerating software delivery while not compromising on quality.
• As a Quality Engineer, you have the opportunity to accelerate the delivery and to improve the quality of the software we build through recommending and implementing automated test suites.
• Work with the supporting vendors, government agencies, and the teams to identify end-to-end test scenarios as well as to automate these test scenarios, applying risk-based strategy to minimize manual interventions.
• Conduct research on emerging technologies that can optimize and accelerate the project delivery.
• Ensure all required testing documentation are in place as part of production preparation checks.
• Drive and advocate continuous improvement in testing practices and tools.

Requirements

• Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology, or related disciplines
• Minimum 3 years' experience in application exploratory testing and regression test automation
• Understanding of Web-based project test methodology, test environments, bug life cycle, and frequent code release deployment QA support
• Create, review and/or support test automation strategies and implementations
• Experience working with highly trafficked, scalable Web applications
• Troubleshooting/debugging skills
• Meticulous attention to details
• Good analytical, interpersonal and presentation skills
• Keen to share knowledge with team mates
• Curious, open to new ideas
• Quick to learn new skills
• Proactive, self-driven and motivated

Bonus points for:

• ISTQB, CSQA, CSTP or other relevant certification
• Experience with Katalon Recorder and/or Katalon Studio or equivalent
• Advanced knowledge of common desktop and mobile browser technology

What do we offer?

• Fun working environment
• Employee Wellness Program

Does it sound like something you are interested in exploring further? Please be in touch with our team for an initial chat at [email protected]

Activate Interactive Singapore is an equal opportunity employer. Employment decisions will be based on merit, qualifications and abilities. Activate Interactive Pte Ltd does not discriminate in employment opportunities or practices on the basis of race, colour, religion, gender, sexuality, national origin, age, disability, marital status or any other characteristics protected by law.

Protecting your privacy and the security of your data are longstanding top priorities for Activate Interactive Pte Ltd.

Your personal data will be processed for the purposes of managing Activate Interactive Pte Ltd’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results, and as is otherwise needed in the recruitment and hiring processes.

Please consult our Privacy Notice (https://www.activate.sg/privacy-policy) to know more about how we collect, use, and transfer the personal data of our candidates. Here you can find how you can request for access, correction and/or withdrawal of your Personal Data.

Job description

Non-Destructive Testing (NDT) technicians examine structures,vehicles, and products for flaws and structural weaknesses usingnon-destructive testing techniques. They conduct material tests,interpret the results, and generate reports on their findings.

Requirements

Bachelor's degree in mechanical engineering, structural engineering,or a similar field.

Relevant NDT certification.

10+ years' experience as an NDT technician.

Advanced knowledge of NDT technologies including ultrasound,infrared, and radiographic.

• Prepare quality reports, perform process audit, develop & implements quality assurance standards, policies, processess & controls.
• Able to liaise & resolve with customers on quality related issues.
• Data compliation, co-ordination and facilitation of all internal and external audits, re-certification of ISO 9001.

Astek has an opening of Quality Engineer role for our projects in Singapore.

Responsibilities:

• Develop and maintain automated test cases, test plans, and test frameworks, ensuring alignment with evolving requirements and policy changes.
• Build, enhance, and manage the automated test framework and test environments.
• Execute testing on new features and document any defects identified.
• Conduct a variety of tests, including manual, functional, performance, and exploratory, while also supporting User Acceptance Testing (UAT).
• Assist in troubleshooting and resolving production issues.

Requirements:

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• 3-5 years of professional software quality testing experience, with hands-on automation expertise.
• Strong knowledge of testing methodologies, risk analysis, and test-driven development.
• Proficiency in Java or Kotlin, with Spring Boot knowledge a plus.
• Experience with automated testing frameworks like Cucumber, TestNG, Playwright, and performance tools like JMeter or LoadRunner.
• Familiarity with penetration testing tools such as ZAP, Burp Suite, and CheckMarx.
• Proven ability to work in SCRUM teams with excellent communication and collaboration skills.

Our client is a US MNC and a Fortune 500 Company that provides Design and Manufacturing solutions to the customers worldwide. They are currently hiring for a Quality Director and will like to invite interested candidate to submit your detailed resume to [email protected]

Quality Director

Responsibilities:

• You will be part of the site Management Team
• Manage entire site Quality system which includes Medical system
• Responsible for all product quality issues, including managing internal and external communication on product qualities.
• Identifies on-going quality issues and makes recommendations to improve current processes
• Interfaces with customers, suppliers, engineering and operational groups on quality related issues
• Responsible to lead 5S & 6 sigma initiatives for the Region
• Provides training in statistical concepts and techniques
• Establish, review & approve quality control methods and procedures
• Plays a key role to provide guidance to site with respect to maintaining quality excellence

Requirements:

• Degree in Mechanical or Electronic / Electrical Engineering or Quality Management with minimum 10 years relevant experience in Quality &/or Management capacity preferably in EMS environment & prior experience in handling FDA audit is preferred
• Excellent knowledge & implementation experience in Six Sigma
• Formal training in ISO Lead Auditor is a definite advantage
• Familiar with ISO-13485 & TL (Telecommunication ) system
• Strong skills in facilitation, analysis & problem solving
• Experience in analyzing of various processes barriers and using TPM methodology to drive improvements and inspection to support operations
• Candidates with Black Belt or Master Black Belt in Lean / Six Sigma will have added advantage
• Ability to work independently with excellent interpersonal relations and deep passion for driving product quality are essential

Element has an opportunity for an experienced Quality Engineer. Reporting to the Principal Quality Manager, you are an essential member of the management team and responsible for the overall quality performance. This includes implementation, maintenance and improvement of Element quality management system (QMS). The successful candidate will have a sound working knowledge of ISO/IEC 17025, ISO/IEC 17020 or ISO/IEC 17065 requirements in relation to testing, calibration inspection and certification.

In this role, you will have interaction with clients, Accreditation Bodies and will be responsible for advising operational colleagues of the importance of quality, accuracy and integrity in the provision of the testing, calibration inspection and certification services we provide.You will be involved in leading quality at a local level and will work closely with the Principal Quality Manager to ensure that Element quality policies, processes and procedures are effectively implemented. As a quality leader within Element you will be capable of driving a culture of quality assurance and quality improvement, working closely with your operational colleagues and the wider Element quality community.

This role is based in Sungei Kadut Loop, Singapore.

Job Duties:

• Ensuring all staff buy-in to the effective and efficient implementation of Element quality policies and procedure by providing advice, guidance and support on quality issues to Element Singapore and Malaysia business units.
• Driving quality improvements at every opportunity and proactive participation in continuous improvement and process improvement projects and ensure effective adoption of Element e-QMS throughout Element Singapore and Malaysia business units.
• Proactive participation in projects to deliver identified Quality objectives and contribute to and drive key initiatives to improve Quality awareness and compliance.
• Management of and participation in scheduled internal audits across management system and technical disciplines and proactively monitoring laboratory test equipment for calibration currency and advising management of upcoming schedules,ensuring corrective and preventive actions identified within specific laboratories are implemented and verified in a timely manner.
• Represent Element Singapore and Malaysia business units during assessments by accreditation bodies and audits by clients and controlled document holding and arrange to update appropriate documentation as necessary, control and issue of Element Singapore and Malaysia Quality Management Systems documentation and participate in the internal audit programme to monitor implementation of quality policies and procedures.
• Manage external and internal proficiency testing programs of all Element Singapore and Malaysia business units and prepare compliance and improvement metrics for Element Singapore and Malaysia business units quality as required.
• Writing and reviewing quality documentation as required and effective and efficient management of personal work schedules and timely generation of Element Singapore and Malaysia business units quality reports.

Job Requirements:

• Minimum Bachelor of Science or Engineering qualification.
• Proven experience (minimum two years) of managing quality management systems within a multi-discipline testing, inspection and certification environment, preferably multi-location.
• Demonstrable experience auditing against ISO/IEC 17025, ISO/IEC 17020 and ISO/IEC 17065.
• Sound knowledge of equipment calibration and analysing proficiency test data.
• Knowledgeable in uncertainty of measurement and risk assessment and hands-on experience with Element e-QMS preferable.

HOW TO APPLY:

Interested applicants, please submit your updated resume to [email protected]

Please state your availability, current & expected salaries for processing purpose. All applications will be treated in the strictest confidence. We regret that only shortlisted candidates will be notified.

• MEP Contractor
• Basic up to $5000
• Office hour 6 days
• Bus from MRT Pioneer

Job Responsibilities:

• Oversee quality checks for incoming, in-process, and outgoing products, ensuring adherence to inspection criteria, quality plans, and finishing work per method statements.
• Work with QA, Process, Engineering, and Product teams to address quality issues, perform audits, and implement corrective actions.
• Manage and control supplier quality standards, ensuring compliance with required specifications.
• Prepare inspection reports, coordinate site visits, and liaise with Project Managers, Engineers, and Authorities for certifications.
• Provide training to workers on method statements and ensure compliance with construction and quality standards.

Job Requirements:

• Minimum ITE, Diploma, or Degree in Manufacturing or Quality Engineering.
• Preferably at least 2 years of experience in a Product Manufacturing environment.
• Knowledge of ISO standards (9001, 14001, 13485, 45001) is a plus.
• Understanding of quality requirement of DMA Modular Prefab MEP product, Materials Selection, Fabrication, Assembly and Inspection will be an advantage.

For consideration, kindly submit your CV by clicking “APPLY NOW” or email to [email protected] for confidential discussion.

*Only shortlisted candidates would be notified**

MTC Consulting Pte Ltd | 15C7752

EA. Registration No.: R24124448 | Nana Yeoh Li Xuan

Need to know Zeiss CMM Program

Need to Know Zeiss CMM Operation

Have Quality Assuarnce & Quality Control Knowledge

Know incoming / In-process / External provider parts insepection

Know prepare of quality documentation and maintenance documents like daliy Monitoring Data and Monthly Data performance

Will preapare of documentation for customer audit and ISO audit

Roles & Responsibilities

The RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and regulatory strategies are effectively implemented and quality systems are maintained and improved.

Key Responsibilities:

(a) Prepare good quality technical documentation.

(b) Manage regulatory submissions for pre-market product registration, renewals, and amendments to ensure timely market entry and compliance.

(c) Stay up to date on evolving regulations and guidelines and provide guidance to internal teams on regulatory landscape.

(d) Monitor post- market surveillance and timely reporting to regulatory authorities.

(e) Prepare and support internal audits, regulatory inspections and audits by notified body, regulatory agencies, partners, and addressing any findings or non- compliance issues that arise.

(f) Support supplier management and audits.

(g) Manage and maintain the effectiveness of Quality Management System (ISO 13485).

(h) Develop, implement and maintain SOPs and quality processes.

(i) Provide training to employees on regulatory and quality requirements.

(j) Responsible for database, processes and systems within RAQA.

Qualifications and Competency

(a) At least Bachelor’s degree in Life Sciences, Biomedical Engineering or a related field.

(b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical device industry.

(c) In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc)

(d) Strong knowledge and understanding of ISO 13485, GMP, regulatory and quality standards

(e) Excellent project management, organizational and problem solving skills

(f) Strong attention to details with the ability to manage multiple priorities and deadlines.

(g) Excellent written and verbal communication skills

(h) Proficient in Microsoft Office

(i) Background in medical device manufacturing would be an added advantage.

Highlight:

• Permanent job opportunity
• Great remuneration & benefits
• Great career progression
• Fun & fast pace environment
• With good expeirence in ISO 13485 and ISO 19001 is preferred.
• Location: North East

Responsibilities:

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Requirements:

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

HOW TO APPLY:

Interested applicants, please send your latest resume to [email protected] or click on “Apply Now” and provide the below details in your resume.

• Last drawn salary
• Expected salary
• Notice period
• Reason of leaving

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

Please read our privacy statement on our corporate website www.trustrecruit.com.sg.

Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Lim Dick Sern (Dick Sern)

EA Personnel Reg No: R22106832

Responsibilities:

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

Requirements:

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

HOW TO APPLY:

Interested applicants, kindly click on “APPLY NOW” or send your resume in MS WORD format to hestia.wong(at)trustrecruit.com.sg

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

Please read our privacy statement on our corporate website www.trustrecruit.com.sg.

Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Wong Ying Huan (Hestia)

EA Personnel Reg No: R24122431

Key Highlights

• Contract Duration: 6 months
• Nearest MRT: Stadium
• Salary: $3,500 - $5,000 per month
• Working Arrangement: Monday – Friday (Office Hours)

Responsibilities

• Review and improve the ISO (International Organization for Standardization) documentation for preparation of internal and external audits. Validate that all documents are updated and recorded as per requirements
• Validate documents compliance and document findings
• Oversee the review and digitalisation of ISO forms
• Conduct review of improvements on Workplace Safety & Health (WSH) incidents and recommend improvements
• Review risk assessment plans to comply with the WSH Act
• Prepare PowerPoint on sharing and learning on safety for stakeholders
• Collate data and conduct trend analysis on incident and summons/warning letters etc
• Introduce, review, and revise quality standards and specifications for safe operations, focusing on regulatory requirements for fire safety, water rides safety, and water quality
• Validate that the venues, programmes and major events comply with regulatory standards and safety policies
• Organise training needs analysis and recommend safety trainings for staff and stakeholders
• Coordinate Occupational Health & Safety (OHS) Committee and Senior Management meetings
• Implement work improvement teams in the organization
• Coordinate safety initiatives and campaigns
• Manage data collection and analysis for safety initiatives and quality assurance projects

Requirements

• Diploma and/or Degree in any field.
• Experience in safety management, sports, project management and/or event organization will be advantageous.
• Registered MOM Workplace Safety and Health Officer, SCDF Fire Safety Manager, or BCA Ride Manager, with strong expertise in local safety regulations, risk management, and investigation processes will be preferred.
• Able to communicate in a clear and confident manner, written and verbal.
• Strong team player.

Interested candidates please click "Apply Now". We regret to inform you that only shortlisted candidates will be contacted for further discussion.

Wong Xue Ying

BGC Group Pte Ltd

EA License No: 05C3053

Registration No. R22108799

We are currently looking for an Electrical, Instrumentation & Control Engineer to support multiple projects in Singapore.

Your day to day role would involve the following activities:

• Experience across a broad range of site electrical and instrumentation engineering projects; experience in industrial buildings (Pharmaceutical, Food or Mission Critical projects) would be an advantage
• Progress reporting and manhour control for the electrical and instrumentation scope.
• Participate in troubleshooting and root cause investigation
• Work closely with calibration vendor and site team

We would like to hear from candidates who have:

• Min Degree in Electrical Engineering or its equivalent
• Min 6 years of relevant working experience in loop check, read drawings in building construction industry.
• Good knowledge of electrical and instrumentation specifications & requirements
• Be able to work independently with minimum guidance and under pressure to meet tight deadlines
• A strong ethical approach to safety, quality, environmental protection and business
• A proven track record working closely in partnership with clients and contractors

Our client is an international freight-forwarder and shipping company. Due to expansion, it is seeking like-minded individual who is experienced in Control Tower Operations (Air and Sea freight) to join their team. The role requires more than operational experience - requires management experience who's willing and able to perform ground work for now, to kick off the South East Asian operation.

Responsibilites:

• Handles end-to-end all the operations for air & sea bookings, including document handling and creation.
• Agent and partner communication and tracking throughout the process.
• Internal communications between offices/ clients on shipments.
• CargoWise file creations and management.
• Ensure systems are kept up to date throughout the process.
• Ensure processes are being adhered to throughout shipping process.

Requirements:

• Minimum 3 years experience in Logistics
• General knowledge of Imports / Exports / General Logistics / Warehousing/ Customs / Rate Understanding
• Sea freight and Airfreight knowledge (Importing and Exporting / Cross Trades)
• SE Asia Knowledge
• Microsoft Office: Word / Excel / Microsoft Outlook
• CargoWise (if possible)
• Well groomed. Team-orientated. Enthusiastic, Passionate, Energetic, Proactive, Organized and self-motivated.
• Determined to progress in career and grow the business
• Good planning skills and very organized in ones work priorities.
• Willing to learn outside of specific job role
• Prepared to work overtime and not afraid of increased workload
• Able to deal with conflict and be able to confront people on issues

Interested candidates are invited to send in your resume in MS Word Format stating your past work experience, reasons for each leave, past and expected remuneration.

We regret to inform that only shortlisted candidates will be notified.

By submitting an application to us, you will be deemed to have agreed for us to collect, use and disclose your personal data which you have submitted to your prospective employers, for the purpose of job search, and/or other services which you have consent us to perform on your behalf.

EA License: 19C9782 (Cultivar Asia Pte Ltd)

EA Personnel: R1326341

Job Description

• Assess the technical and commercial feasibility of the project in line with our organization's capabilities and financial considerations.
• Create cost and effort estimates to prepare technical and commercial proposals.
• Attend client briefings to establish expectations, key performance indicators (KPIs), service level agreements (SLAs), and related protocols.
• Conduct thorough site assessments to determine the actual scope of work, associated risks, and challenges.
• Plan the manpower, materials, tools, equipment, and supervision requirements for the site while considering the budget and contract specifications.
• Develop action plans to improve the effectiveness of pest management operations.
• Procure and allocate mechanized and automated equipment for pest management tasks.
• Participate in new product launches related to pest management and service enhancements.
• Schedule work for teams to ensure efficient pest management.
• Clearly communicate roles, responsibilities, and performance expectations to site supervisors.
• Offer advice on technical and workforce-related challenges related to pest management work.
• Evaluate site operations to monitor progress and allocate resources efficiently.
• Review collected data to establish or revise procedures, protocols, and guidelines for pest management on-site.
• Enforce workplace safety and health (WSH) regulations.
• Assess the risks associated with on-site pest management and establish safety procedures and protocols.
• Resolve conflicts, grievances, and disputes among staff.
• Oversee the development of staff skills and capabilities.
• Create plans to foster strong teamwork in line with the organization's core values.
• Analyze and manage significant incidents and emergencies in collaboration with relevant parties.
• Make crucial decisions to address significant incidents and emergencies.
• Review reports related to incidents and emergency situations.
• Manage and report on incident and emergency investigations.

Requirements

• Possess with at least Diploma, Degree or above in Business, Environmental, Science or related field.
• At least 5 years supervisory experience, preferrable in environmental service experience.
• Valid Pest Control License and IRATA Level 2 / 3.
• Valid Class 3 license
• Able to multi-task and work independently, with a hands-on approach to meet a tight timeline
• Able to start work immediately or within short notice
• Experience in leading and managing a business unit preferred.
• Proficient in MS Office Word, Power Point and Excel
• Good interpersonal, communication and organizational skills
• Meticulous and pro-active
• Able to work in a fast-paced environment.

Job Description

• Assess the technical and commercial feasibility of the project in line with our organization's capabilities and financial considerations.
• Create cost and effort estimates to prepare technical and commercial proposals.
• Attend client briefings to establish expectations, key performance indicators (KPIs), service level agreements (SLAs), and related protocols.
• Conduct thorough site assessments to determine the actual scope of work, associated risks, and challenges.
• Plan the manpower, materials, tools, equipment, and supervision requirements for the site while considering the budget and contract specifications.
• Develop action plans to improve the effectiveness of pest management operations.
• Procure and allocate mechanized and automated equipment for pest management tasks.
• Participate in new product launches related to pest management and service enhancements.
• Schedule work for teams to ensure efficient pest management.
• Clearly communicate roles, responsibilities, and performance expectations to site supervisors.
• Offer advice on technical and workforce-related challenges related to pest management work.
• Evaluate site operations to monitor progress and allocate resources efficiently.
• Review collected data to establish or revise procedures, protocols, and guidelines for pest management on-site.
• Enforce workplace safety and health (WSH) regulations.
• Assess the risks associated with on-site pest management and establish safety procedures and protocols.
• Resolve conflicts, grievances, and disputes among staff.
• Oversee the development of staff skills and capabilities.
• Create plans to foster strong teamwork in line with the organization's core values.
• Analyze and manage significant incidents and emergencies in collaboration with relevant parties.
• Make crucial decisions to address significant incidents and emergencies.
• Review reports related to incidents and emergency situations.
• Manage and report on incident and emergency investigations.

Requirements

• Possess with at least Diploma, Degree or above in Business, Environmental, Science or related field.
• At least 5 years supervisory experience, preferrable in environmental service experience.
• Valid Pest Control License and IRATA Level 2 / 3.
• Valid Class 3 license
• Able to multi-task and work independently, with a hands-on approach to meet a tight timeline
• Able to start work immediately or within short notice
• Experience in leading and managing a business unit preferred.
• Proficient in MS Office Word, Power Point and Excel
• Good interpersonal, communication and organizational skills
• Meticulous and pro-active
• Able to work in a fast-paced environment.

Requirements

• Candidate must possess at least Professional Certificate in Engineering (Environmental/Health/Safety) or equivalent.
• At least 3 Year(s) of working experience in the related field is required for this position.
• Preferably Non-Executive specialized in Engineering - Environmental/Health/Safety or equivalent.

Responsibilities

The role of an Environmental Control Officer (ECO) is basically to look out for conditions/ situations in construction sites which cause environmental health problems or are likely to cause environmental health problems. He should report these conditions/ situations to the contractor together with recommendations on remedial measures to be taken to prevent recurrence.

The main areas where the ECO should pay attention to are as follows:

• Disease-bearing insects and rodents
• Proper disposal of construction waste
• Noise, air and dust pollution
• Earth littering
• Siltation of drains
• Food hygiene in canteens
• Any other environmental health matters