Job Description:

• In charge of performing quality assurance functions with regard to the product, process and maintain quality management system while ensuring compliance with all customers’ requirements
• Responsible for reviewing and revising quality procedures and quality control instructions
• Liaise with customers / vendors / suppliers on non-conformance activities, perform root cause analysis and determine effective corrective actions to reduce or eliminate the cost of poor quality
• In charge of performing internal audits to evaluate quality system, products, and processes
• In charge of performing vendors’ and on-site audits as required
• Drive down monthly Cost of Poor Quality/ scrap

Requirements:

• Degree in Mechanical / Aeronautical Engineering / other relevant disciplines
• Minimum 2 years of experience in Quality Management System and NADCAP

Position Overview:

As the Quality Manager, you will be responsible for ensuring the highest quality standards in the development and production of biomedical products. You will lead and manage quality assurance activities across the production process, ensuring compliance with regulatory requirements, industry standards, and company policies. You will play a pivotal role in driving continuous improvement initiatives and fostering a culture of quality within the organization.

Key Responsibilities:

• Oversee and manage the company's Quality Management System (QMS), ensuring compliance with ISO 13485, FDA regulations, and other applicable standards.
• Develop, implement, and maintain quality assurance policies and procedures.
• Lead quality audits, internal and external inspections, and regulatory compliance assessments.
• Monitor and report on quality performance metrics, identifying trends and areas for improvement.
• Manage the resolution of non-conformances, corrective actions, and root cause analysis.
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs) to ensure product quality throughout the product lifecycle.
• Ensure proper documentation and traceability for all quality-related activities.
• Train and mentor staff on quality processes and regulatory requirements.
• Maintain relationships with regulatory bodies, customers, and suppliers to ensure ongoing compliance and quality standards.

Job description

A reliable Engineer of Quality Assurance to ensure that all external and internal requirements are met before our product reaches our customers. She will be responsible for inspecting procedures, outputs and identifying mistakes or non-conformity issues.

An excellent Engineer with industry proficiency in 2D/ 3D dimensional inspection, Knowledge of geometric measurements and CMM. She is equipped with rich experience, quality control background with eagle eyes and if obtained a certification of ISO 13485/ 9001 Quality Management Systems Internal Auditor added an advantage.

A reliable, trustworthy and competent professional whose approval will be necessary for the continuation of a business life cycle. The goal of the quality management system is to assure the high quality of our operations and services aiming to the long-term success of our business.

Duties & Responsibilities

1. Conduct the training of ISO 9001:2015/ 13485:2016 for work procedures to operation and production

2. In-house training to guide inspectors, technicians and other staff for engineering symbol & geometric dimensioning & tolerance drawing quality specification

3. Supervise equipment and tools are duly calibrated

4. Devise procedures to inspect and report quality issues

5. Assure the reliability and consistency of production by checking processes and final output quality of finished parts/ components and materials

6. Monitor all operations that affect quality

7. Report all malfunctions to production manager to ensure immediate action

8. Implement corrective action (CAR) / non-conforming report to operations effectively

9. Facilitate proactive solutions by collecting and analysing quality data

7. Keep records of quality reports, statistical reviews and relevant documentation

8. Review current standards and policies, work procedure (SOP), and update written procedures (DCN), engineering work instructions or specifications (ECN)

9. Work as a team to evaluate, validate customer quality issues and complaints, or/ and special quality requirements from customers for quality assurance on geometric symbol, tolerance and dimensioning

10. Communicate with external quality assurance officers during on-site inspections

11. Appraise customers’ requirements and make sure they are satisfied

12. 5.5-day work week

Requirements

Ability to read and interpret engineering drawings is a strong advantage

1. Degree/ Diploma in engineering or relevant field

2. Proven experience as a quality assurance engineer or relevant role

3. Thorough knowledge of methodologies of quality assurance and standards

4. Excellent numerical skills and understanding of data analysis/statistical methods

5. Resourceful and attention to detail and a results driven approach

6. Excellent organizational and leadership abilities with good communication and interpersonal skills

质量工程师（Quality Engineer)

Responsibilities:

To manage the Quality Assurance & Quality Control (QA/QC) function so that quality products/services are supplied.

Liaison with customers, consultants, engineers, inspection bodies and suppliers on matters relating to quality assurance.

Coordinating with Production/Plant Managers to conduct investigations on quality deficiencies.

Conduct site visits to ensure that quality of products supplied is within design parameters.

Co-ordinate all QA/QC operations to ensure that customers are satisfied with the level of products/service provided.

Co-ordinate with the Sales and Production Departments to ensure that customer complaints are professionally and efficiently resolved.

Develop QA/QC systems and set achievable targets

Ensure Production comply with quality procedures.

Assist Project Management team on project/safety for daily activities and Quality Management

Work with Production Manager and Plant Manager to minimize defects

Comply with all requirements for the continuity of ISO certifications

Requirement:

Relevant Qualifications in Engineering or equivalent

possess training certificate in ISO Quality Management System, Quality Engineer, CONQUAS, BCA-Good Industry Practices would be advantageous

Comfortable working within a fast-changing environment, ability to multi-task and cope with ambiguity

Strong communication and interpersonal ability, coupled with influencing skills

Independent and a self-starter, with strong personal drive to initiate and implement

Job Description & Requirements

Perform inspection including the use of gages and equipments and document quality paperwork meeting the Engineering Print, Job Instruction Sheets and/or the QMS Instructions. To support all CORE, EH&S and Continuous Improvement activities.

Roles and Responsibilities

• Perform job inspection at first piece, in process and final inspection per the Job Instructions Sheet plans.
• Perform First Article Inspection (FAI) and Delta FAI per AS9102 requirements.
• Perform dimensional inspection using a variety of inspection gages & equipment.
• Initiate Quality Notification (QN) for non-conformance when products are not meeting Quality and Engineering requirement.
• Perform proper use and maintenance of gages and inspection equipment.
• Perform proper documentation including inspection stamping of quality paperwork.
• Maintain and improve 5S standards on workstations and responsible areas.
• Good communication and interpersonal skill and ability to communicate with all levels.
• Adhere to company EH&S policies and guidelines.
• Adhere to company Quality Policy.

Qualification and Education Requirements

• Minimum Education required (specific field or equivalent):
• NITEC qualification in Precision/Mechanical Engineering or higher.
• Minimum years of experience in role: At least 2 years of working experience in a quality control environment.

Preferred Skills (if any):

• Able to interpret basic technical (GD&T) drawings.
• Proficient in using hand gages; micrometer, dial indicator, height gage etc.
• Good command of written and spoken English.
• Basic operating knowledge of Co-Ordinate Measuring Machine (CMM) inspection; Carl Zeiss / Wenzel CMM.
• General proficiency of Microsoft Excel and Microsoft Word (SAP a plus).
• Non Destructive Testing (NDT) method in MPI Level 2 will be an added advantage.
• Able to perform weekly rotating shifts.

Working Location: Bedok South

Our Client:

• Cranes Lifting Industry
• 5 Days, Office Hours
• West Region
• Up to $4300 Per Month

Responsibilities:

• Investigate all incidents and product nonconformity to identify causes and ways to prevent occurrence in future.
• Support and promote the company incident report and management system.
• Provide guidance to business on consistency of HSE and QMS expertise by participating in Management reviews and audits.
• Monitor company’s ISO 9001 Management System are implemented and maintained in Singapore and Malaysia.
• Control of system documentations and procedures for Southeast Asia including Australia.
• Coordinate with business on training and holding of dialogue sessions with relevant customers, contractors, suppliers to ensure awareness and compliance with all HSE requirement impacting company operations.
• Ensure quality procedures are adhered throughout organisation and highlight noncompliance.
• Conduct quality check and inspection on manufacturing and installation processes pertaining to current range of products.
• Recommend quality control and inspection requirements in consultation with regional HSE and QMS whenever necessary for final review and approval by region director for implementation.
• Participate in HSE committee meetings and implement HSE procedures and standards in all workplace activities to achieve the required safety standard.
• Chair monthly QIP meeting and submit monthly quality report.

Requirements:

• Qualification in Engineering, Safety or Quality.
• Minimum 2 years of working experience in QA/QC in a manufacturing or construction environment.

For interested applicants, please click "Quick Apply”

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

By submitting your personal data and/or resume, you will be deemed to have agreed and consented to us collecting, using, retaining, and disclosing your personal information to prospective employers for their consideration.

Quay Choon Lan Joanne (Guo Chunlan) | EA Reg No: R24121479
JTE Recruit Pte Ltd | EA Lic No: 14C7215

The summary of the scope of activity as below:

1. Revise and review SOPs

2. Review executed MBR/EBR

3. Support manufacturing team with any quality interpretation , queries and issues.

4. Provide quality oversight (participate GEMBA walk, GMP walk)

5. Perform archival of QO documents

6. Perform IQ and OQ. Involve in URS, design specifications

Requirements

• Min Degree in science / engineering related courses
• Min 2 to 3 exp of Quality experience from pharma / Medical industry
• Able to start work immediately

Up to $8K (For Senior role) x 1

Up to $6K (For junior role) x 1

Pharma MNC

Interested candidates, please forward your resume to [email protected]

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)

About Us:

VisionPower Semiconductor Manufacturing Company Pte Ltd (VSMC) is a new joint-venture 300mm semiconductor wafer manufacturing facility to be built in Singapore. We are looking for committed, resilient and passionate talents to launch a promising future that power the next generation devices and systems. If you share the same passion to pursue excellence, join us to make an impact and be part of something special!

Role Summary:

You will be responsible in leading a reliability engineering team to execute transfer technology qualification, reliability monitor, process change evaluation, and manage customer-focused reliability requirements.

Key Responsibilities:

• Establish reliability test laboratory and manage the daily operation.
• Implement and optimize reliability test methodologies, ensuring alignment with industry standards and client expectations.
• Conduct qualification specifications for transfer technologies, guiding teams in the development and execution of testing methodologies.
• Manage the execution of reliability qualification processes, ensuring continuous monitoring and timely interventions for corrective actions.
• Apply advanced statistical tools and quality assurance methods to proactively detect and address potential reliability issues.
• Assess reliability risks for customer products, providing strategic guidance to mitigate potential issues.
• Manage worldwide customer reliability specifications and requirements.

Education Qualification & Essential Experiences:

• Bachelor's degree or higher in EE/Physics/Material Science or other related engineering discipline.
• At least 15 years of experience in Integrated Circuit process and Reliability Assurance management.
• Strong knowledge of semiconductor device physics, wafer-level reliability, and statistical quality control methods.
• Experience in risk assessment and developing corrective action plans.

Personal Attributes:

• Strong leadership skills
• Excellent interpersonal, written, and verbal communication abilities.
• Ability to multitask effectively and solve problems efficiently.
• Enthusiastic and able to motivate a team to achieve exceptional results.

VSMC promotes diversity and inclusivity in our workforce; and hiring will be conducted in phases.es.

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

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

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.

At Baker Tilly Singapore, we welcome highly motivated and committed individuals who share our core values to join us. We are committed to our values of leading by example, delivering quality services with integrity, communicating openly, acting ethically, and fostering a community built around civic responsibility and teamwork.

We are looking for an Assurance (Financial Services) Associate, who will be involved in various sizes of financial services audit engagements which include planning, performing, and concluding the engagement. The Assurance Associate will be exposed to a broad range of capital markets entities and investment funds such as private equities, real estate, mutual funds, variable capital companies, etc.

In this role, you will:

• Involvement in a broad range of statutory and regulatory audit assignments for our financial services clients

• Assist in obtaining all necessary audit working papers and documentation including researching and documenting facts and findings

• Identify and communicate accounting and auditing matters to managers and partners

• Identify performance improvement opportunities

• Interact with clients to help ensure that the information flow from the client to the audit team is efficient

We are looking for people with the following:

• Graduates with an Accountancy degree or equivalent professional qualification in Accountancy

• Accountancy undergraduates in the final year of study are welcome to apply

• Graduates with non-accountancy degrees who are keen to pursue qualifications as Singapore Chartered Accountants are welcome to apply

• Good command of the English language

• Strong interpersonal and client relationship skills

• Experienced candidates will be considered for the Senior Associate position

We regret that only shortlisted candidates will be notified.

Our client is a well-established MNC, market leader in the 3PL Logistics industry. Due to their current expansion plan, they are looking for Quality Executive, in hopes of developing the current high performing team. They are located in the East - easily assessible.

Responsibilities:

• Conduct daily meetings to address logistics-related manufacturing NCs.
• Validate defects with QC support, providing corrective action recommendations.
• Resolve logistics issues with proper containment and corrective measures.
• Manage complaints, perform root cause analysis, and implement improvements.
• Lead quarterly audits, report findings, and ensure timely closures.
• Prepare quality guidelines and instructions.
• Oversee raw material warehouse quality supporting manufacturing.
• Compile weekly, monthly, and quarterly logistics reports for customer review.

Requirements:

• Min Degree in Supply Chain or related study
• Min 3 years of quality experience in manufacturing setting, well wersed in methodologies such as CAPA, GDPMDS and Six Sigma

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

We believe that challenges are best solved together. That’s why, when you join us, you become part of a diverse and global community of problem-solvers. You'll find an unexpected mix of people who bring their unique expertise to build trust in society and tackle important issues. Here, we welcome and encourage you to lead with value and inspiration, question and challenge assumptions, as well as embrace new opportunities to deliver quality outcomes in exciting and unexpected ways, all with the support of technology.

Our Financial Services Assurance Practice works with organisations to strengthen trust and transparency by building, maintaining and providing trust over financial reporting in a fast changing, technology-driven world. As Asia’s top financial services practice, our audit approach is at the leading edge of best practice. We draw upon our extensive industry knowledge for our clients including top blue chip companies in the asset management, banking, capital markets, and insurance sectors. We provide our clients with insights, empowered by leading technologies, into marketplace developments and global opportunities.

Key responsibilities:

• Involvement in a broad range of statutory audit assignments for our financial services clients
• Potential involvement in selected advisory assignments which could include providing advice on accounting for complex arrangements and instruments, internal control & risk management reviews, financial due diligence and transactions support (amongst others)

Requirements:

• Degree holder in any discipline
• Professionally qualified preferred
• Min. 1 year and above of relevant experience with an international public accounting firm, with extensive experience in statutory and regulatory audits of Banking & Capital Markets, Insurance and Asset Management clients
• Strong interpersonal, written and verbal communication skills
• Excellent team working skills

*Only shortlisted candidates will be notified due to the high number of applicants for this role.

We believe that challenges are best solved together. That’s why, when you join us, you become part of a diverse and global community of problem-solvers. You'll find an unexpected mix of people who bring their unique expertise to build trust in society and tackle important issues. Here, we welcome and encourage you to lead with value and inspiration, question and challenge assumptions, as well as embrace new opportunities to deliver quality outcomes in exciting and unexpected ways, all with the support of technology.

Our Financial Services Assurance Practice works with organisations to strengthen trust and transparency by building, maintaining and providing trust over financial reporting in a fast changing, technology-driven world. As Asia’s top financial services practice, our audit approach is at the leading edge of best practice. We draw upon our extensive industry knowledge for our clients including top blue chip companies in the asset management, banking, capital markets, and insurance sectors. We provide our clients with insights, empowered by leading technologies, into marketplace developments and global opportunities.

Key responsibilities:

• Involvement in a broad range of statutory audit assignments for our financial services clients
• Potential involvement in selected advisory assignments which could include providing advice on accounting for complex arrangements and instruments, internal control & risk management reviews, financial due diligence and transactions support (amongst others)

Requirements:

• Degree holder in any discipline
• Professionally qualified preferred
• Min. 2 years and above of relevant experience with an international public accounting firm, with extensive experience in statutory and regulatory audits of Banking & Capital Markets, Insurance and Asset Management clients
• Strong interpersonal, written and verbal communication skills
• Excellent team working skills

As part of our recruiting process, interested candidates are to complete an application through our career website at https://www.pwc.com/sg/careers.html

*We regret that only short-listed candidates will be notified.

Responsibilities

• Internal and external excursion management (MRB / Quality Claims)
• Customer data reporting
• Conduct Quality related training
• Support customer survey and audits
• Continuous improvement activities

Requirements

• Bachelor's degree in Engineering or Science.
• Strong systematic and analytical problem-solving abilities.
• Proactive attitude with the ability to handle multiple tasks simultaneously.
• Excellent communication skills and a collaborative team player.
• Understanding of system flow and databases; basic SQL knowledge is advantageous.
  

For Experienced Candidates:

• Proven experience with QA tools such as 8D, FMEA, fishbone diagrams, and AND.
• Solid working knowledge of Statistical Process Control (SPC) and auditing practices.

For Entry-Level Candidates:

• Willingness to learn and adapt to new QA tools and methodologies.
• Basic understanding of quality assurance principles and practices.
• Freshgraduate with part time working experience during Uni time (aside from internship) is a plus.

Job Responsibilities:

• Management of Quality Management Systems.
• Support and maintain relevant systems both internally and externally.
• Responsible for Documentation Control system and Audits.

Job Requirements:

• Good working experience.
• Precision manufacturing industry.
• Adequate understanding of Quality Management System.
• Team player with good initiative and proactive.
• Microsoft office.

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.

Job Responsibilities:
- Maintains the Company Integrated Management System, ensuring all business processes are documented, have a designated owner and a plan for their maintenance, aligned to Survitec strategy and associated accreditation and/or regulatory frameworks.

- Perform internal audit procedure and schedule as per Department audit plans, to include the audit Scope, Objective and Criteria. Deliver the audit report including findings; agree on corrective actions with auditees and refer findings to the Manager.

- Investigate non-conformances using current and appropriate methods, systems, and procedures, taking action to solve immediate compliance issues.

- Identifies shortcomings in quality processes or outputs, identifies root cause and works with internal stakeholder to adjust processes or working practices to remove or mitigate any production quality issues; uses established change management programs to address issues and deliver sustained improvements.

- Attend aviation related training and create/refresh and update on internal company aviation training notes.
Conduct internal company training as per aviation requirements.

- Implements systems to ensure compliance with QHSE policies, group and Customer requirements; ensures audit, inspection and risk management are adhered to and embedded throughout the system.

- Document control system management, revision and updating.

- Defines and communicates the processes and schedule for audit, working with colleagues from the Quality function to ensure all supplier, operational, technical, health, safety and environmental audit activity is carried out as planned.

- Leads and participates in quality, non-conformance and customer complaint investigations.

- Provides written reports on audit and investigation findings, implements and monitors CAPA and improvement actions. Ensures findings are reported and escalated appropriately.

- Works with Survitec QHSE colleagues to develop tools and dashboards for the statistical analyses on which recommendations for improvement are based. Ensures outputs from QHSE reporting tools and dashboards are communicated to and understood by the business.

- Inform manager of audit findings and compliance issues, including capability gaps, workflow issues or matters requiring quality development or improvement.

- Any others tasks/projects as assigned by line manager from time to time.


Job Requirements:
- Degree/Diploma in Engineering (preferably Quality Engineering).

- At least 2 years of Quality Assurance experience in Aviation industry.

- Knowledge of ISO 9001, ISO 14001, and TS 16949.

- Proficiency in statistical tools and Microsoft Office.

- Strong analytical, problem-solving, and communication skills
Certified Internal/Lead Auditor (preferred).

- Train the trainer qualification will have added advantage.

Our client is a well-established MNC, market leader in the 3PL Logistics industry. Due to their current expansion plan, they are looking for Quality Executive, in hopes of developing the current high performing team. They are located in the East - easily assessible.

Responsibilities:

• Conduct daily meetings to address logistics-related manufacturing NCs.
• Validate defects with QC support, providing corrective action recommendations.
• Resolve logistics issues with proper containment and corrective measures.
• Manage complaints, perform root cause analysis, and implement improvements.
• Lead quarterly audits, report findings, and ensure timely closures.
• Prepare quality guidelines and instructions.
• Oversee raw material warehouse quality supporting manufacturing.
• Compile weekly, monthly, and quarterly logistics reports for customer review.

Requirements:

• Min Degree in Supply Chain or related study
• Min 3 years of quality experience in manufacturing setting, well wersed in methodologies such as CAPA, GDPMDS and Six Sigma

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

Our client is a well-established MNC, market leader in the 3PL Logistics industry. Due to their current expansion plan, they are looking for Quality Executive, in hopes of developing the current high performing team. They are located in the East - easily assessible.

Responsibilities:

• Conduct daily meetings to address logistics-related manufacturing NCs.
• Validate defects with QC support, providing corrective action recommendations.
• Resolve logistics issues with proper containment and corrective measures.
• Manage complaints, perform root cause analysis, and implement improvements.
• Lead quarterly audits, report findings, and ensure timely closures.
• Prepare quality guidelines and instructions.
• Oversee raw material warehouse quality supporting manufacturing.
• Compile weekly, monthly, and quarterly logistics reports for customer review.

Requirements:

• Min Degree in Supply Chain or related study
• Min 3 years of quality experience in manufacturing setting, well wersed in methodologies such as CAPA, GDPMDS and Six Sigma

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

The Assurance Senior is expected to lead various sizes of audit engagements which include planning, performing, reviewing of audit work performed by less experienced personnel and concluding the engagement.

Responsibilities

• Work closely with team members to execute the audit plan and ensure timely completion of the audit engagement
• Work closely with clients and manages their expectations to further nurture on-going client relationships
• Able to identify unethical behaviour and react based on the applicable ethical principles

Requirements

• A degree in Accountancy or equivalent professional qualification in Accountancy
• At least 3 years of external audit experience
• Good command of the English language
• Strong interpersonal and client relationship skills

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Summary Benefit:

• Salary range: $2000-$2800
• Location: Tai Seng (Semicon - Cable, Harness)
• Mon to Fri, Office hours
• MNC with great career progression

Responsibilities :

• Conduct incoming inspections and first article checks on raw materials and components based on written procedures and specifications.
• Oversee the calibration system for instruments, including documentation and procedures.
• Use advanced methods like Six Sigma and SPC to develop effective, maintainable quality systems.
• Operate various hand tools and machines such as screwdrivers, soldering irons, and crimpers.
• Oversee and maintain the quality assurance laboratory and support internal and supplier audits.
• Ensure timely completion of inspection requirements, create necessary certifications, and meet daily quality targets.

Requirements :

• Able to read CAD drawings

To Apply, kindly click on the "APPLY NOW" button

We regret that only shortlisted candidates will be notified.

Staffking Pte Ltd (20C0358) | Khor Wan Ying (R22109948)