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 & 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

• Supervise & Lead QA/QC day to day activities including installation and coordination with consultants, main contractors and subcontractors.
• Prepare the ITP by studying project plans and specifications; calculating time requirements; sequencing project elements.
• Controls and implement Quality plan by reviewing material and test specifications, and plan and schedule changes; recommending actions.
• Check, confirm all Quality documents and specifications are complied with company standards.
• Attend the weekly and monthly project meetings to update the status and activity of the project.
• Prepares weekly or monthly project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
• Manage quality control of all construction and testing of the install facilities, equipment and systems.
• Maintains site Quality Standards by enforcing internal procedures, rules, and regulations.
• Maintains product and company reputation by complying with state and company policy and regulations.
• Contributes to project team effort by accomplishing related results as needed.
• Assist Project Manager in the preparation of project Capex, budget estimation and cost allocation.
• Able to work independently and less supervision required.
• Willing to work late or during weekends when required.
• Attend Toolbox meetings with project team onsite.
• With sound knowledge of process piping installation and equipment installation.
• Able to work with the project team in Piping layouts and design specifications.

Requirements

• Graduate of Bachelor's degree in Mechanical or equivalent engineering education.
• Physically fit to work at a construction site as QA/QC engineer.
• More than 3 yrs experience working on site installation and Greenfield project environment.
• Experience working at process/equipment construction site, plant installation, EPC, or equivalent.
• With experience in generating ITP and specification document
• Ability to read, understand & demonstrate the P&ID and PFD drawings to site work.
• Proficient to read and understand engineering plan drawings like piping and pipe support plan, equipment layout mechanical installation plan.
• Proficient with Microsoft office application and Microsoft project or equivalent and familiar with Google doc
• Familiar with Singapore and international codes /Regulations related piping, construction.

Job description

Non-Destructive Testing (NDT) technicians examine structures,vehicles, and products for aws 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 eld. Relevant NDT certication. 10+ years' experience as an NDT technician. Advanced knowledge of NDT technologies including ultrasound,infrared, and radiographic.

• Well Established Company
• Basic $5000 - $6500 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485 | Medical Devices

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability
• Ensure supplier quality issues are deal with, analysed, improved and follow through
• Collect, handle and follow-up on customer feedback/complaints
• Support internal, external and customer audits
• Evaluation, verification and validation of new parts/samples
• Establish and maintain inspection criteria for incoming, in-process and final products
• Identify quality issues, NCR, CAPA handling and drive continuous improvement
• Authorize the release (COC) of products, COA review & approval
• Monthly data analysis on product quality and quality objective
• Review and approval on DHR
• Participate in new projects, commercial product quality management and control
• Drive change management and control
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with 2 years’ experience in medical device QA and/or RA
• ISO 13485:2016 certified internal auditor will be advantageous
• Familiar with quality control tools

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Quality Controller/GAP Coordinator

Job Description

The Quality Control/GAP Coordinator is responsible for ensuring all products received perishable and nonperishable are of standard as per the company’s specifications. This role must also ensure supply security and FIFO practices.

Scope: Singapore (Choa Chu Kang farm)

Working Days: 5.5

Reporting into: Head of Farm Operations

In This Role You Will (Responsibility):

· Ensure incoming and outgoing goods (perishable and non-perishable) meet company and GAP standards.

· Daily inspection of production areas to ensure compliance with company and GAP standards.

· Analyse quality data and summarise findings.

· Generate inspection reports.

· Conduct quality assurance reports.

· Conduct internal self-audits of processes and procedures.

· Prepare quality assurance documents in compliance with local regulations and GAP standards.

· Ensure quality testing (shelf-life samples) and laboratory microbial testing is done in accordance with GAP standards.

· Ensure staff training is done to comply with GAP and Food Safety requirements.

Traits

• Continuously learning and challenge the status quo.
• Willingness to join and grow with a dynamic company.
• Strong bias for action.

· Must be energetic and hands-on to take on new and challenging tasks and to work well with limited resources and a strong sense of accountability.

Assist operation in problem solving and execute improvement initiatives

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

The opportunity: your next adventure awaits

EY Assurance group is one of the most trusted, respected and influential business unit in the industry. As part of our team, you will provide our clients including companies, investors and regulators a peace of mind by using your skills and experience to build confidence in the validity of financial statements and business-critical information or processes.

Emerging and Private Enterprises (EPE)

The EPE sector is set up to address the specific needs of private companies and their stakeholders. It supports the private and mid-market companies through delivering quality audit services and help these companies decide how to grow in a technology-driven and sustainable way. We are moving towards digitalizing audit. To keep pace with the fast-changing world, we are prioritizing investments in AI, predictive analytics, and other emerging technologies to gain a competitive edge, reskilling employees and redesigning jobs to seamlessly integrate people and machines.

You will experience professional development through diverse experiences, world-class learning and individually tailored coaching. We also offer EY Professional Qualification Program that support your professional growth and aspiration. That’s how we develop outstanding leaders who, in turn, deliver on our promises to all our stakeholders, and in so doing, play a critical role in building a better working world for our people, for our clients and for our communities.

Your key responsibilities

• Support the planning, execution and delivery of assurance engagements.
• Perform a variety of assigned tasks and audit work procedures for a portfolio of diversified clients in different industries.
• Clearly and accurately document the execution of specific audit procedures as defined by the engagement objectives, planned audit approach and procedures, and global audit methodology.
• Recognize potential audit issues or unusual relationships from basic analysis of the financial statements and related information and communicate them to the assurance team.

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

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

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

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Description

As a Quality and Compliance Specialist, you will play a pivotal role in ensuring that all products and operations within Project WATT meet regulatory requirements and quality standards. This role focuses on managing product certification, conducting regulatory audits, and ensuring that operational processes align with local and international laws. Collaborating with technical and operational teams, you will safeguard compliance while driving continuous improvement in quality management.

Responsibilities

• Product Quality Compliance:

1. Ensure that all products (hardware and software) comply with relevant regulations and industry standards, such as TR25 for EV charging systems in Singapore.
2. Maintain and update product certifications and manage regulatory audits and inspections.
3. Review testing results and performance reports to verify adherence to quality standards.

• Operational Compliance:

1. Oversee business operations to ensure alignment with legal and regulatory requirements, such as data privacy and environmental standards.
2. Develop, update, and optimize internal compliance policies and procedures to reflect current regulations.
3. Prepare and submit compliance reports, maintaining effective communication with regulatory authorities.

• Team Collaboration:

1. Work closely with technical teams, including Firmware Engineers and Integration Engineers, to validate the compliance of products and systems.
2. Provide compliance guidance and training to other teams to promote a culture of regulatory awareness.

• Risk Identification and Management:

1. Identify potential compliance risks and recommend actionable improvements to mitigate them.
2. Lead quality and compliance enhancement projects, ensuring continuous improvement in these areas.

Requirements

• A bachelor’s degree in Engineering, Quality Management, Law, or a related field, with at least 3 years of experience in product quality or compliance management. Equivalent professional experience will also be considered.
• Strong understanding of regulatory requirements for EV charging systems or IoT products, including certifications such as TR25.
• Experience managing audits and certification processes with regulatory bodies.
• Proven ability to collaborate effectively with cross-functional teams to ensure adherence to compliance and quality standards.
• Strong analytical and problem-solving skills with meticulous attention to detail in documentation and reporting.
• Knowledge of operational compliance standards, such as data privacy laws or environmental regulations, is a plus.

Reporting to:

Project Manager

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

Job Summary
We are seeking a highly motivated Governance, Risk, and Compliance (GRC) professional to join Risk & Assurance (R&A) team in Singapore. The successful candidate will play a pivotal role in strengthening our Control Self-Assessment (CSA) and risk management processes, enhancing the existing Enterprise Risk Management (ERM) framework, and fostering a good risk-aware culture across the organization.

Key Responsibilities
CSA Execution & Coordination

• Implement and support CSA processes aligned with enterprise risk governance standards.
• Identify control gaps and ensure compliance with group policies and regulations.
• Manage the timely completion and closure of CSA activities.

Program Enhancement

• Drive key risk initiatives, including risk tolerance assessments, thematic reviews, scenario analyses, and horizontal reviews through proactive risk monitoring.
• Stakeholder Engagement
• Collaborate with stakeholders to review and update the risk register, control questions, and action plans.
• Act as a bridge between risk and control owners to improve risk understanding and action.

Process Efficiency & Operational Support

• Enhance the GRC platform to improve process efficiency.
• Support operational tasks like GRC administration and compliance training delivery.

Documentation & Reporting

• Continuously improve CSA checklists and reporting templates.
• Generate insightful reports to support risk and control management decisions.

Training & Support

• Deliver training on CSA methodology and GRC platform usage.
• Promote risk awareness and a proactive risk management culture within the organization.

Skill Set Needed
Qualifications

• Bachelor’s degree in Accountancy, Information Security, Business Administration, Finance, Economics, or a related field.
• Professional certification (e.g., CRMA, CIA, CISA, CPA, CA).

Experience

• 6-8 years of experience in risk and control management roles.
• Hands-on experience with ERM tools, CSA processes, and risk culture initiatives.

Technical Skills

• Good understanding of ERM frameworks, regulatory compliance, and risk culture best practices.
• Proficiency in GRC platforms for managing ERM, CSA, and Controls Continuous Monitoring (CCM).
• Experience with data analysis tools like Python, Excel, Tableau, or Power BI for reporting and dashboard creation.

Soft Skills

• Value Creation: Guides stakeholders in achieving organizational objectives and elevating performance.
• Dynamic: Adapts effectively to emerging risks and changing regulations.
• Collaboration: Demonstrates excellent facilitation, presentation, and engagement skills with key stakeholders.

If you are interested in this exciting opportunity, please share your updated resume with us!

EA License Number : 02C3423

EA Personnel Number : R22108699

• Well Established Company
• Basic $3000 - $3500 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 6.30pm

Job Responsibilities:

• Lead and supervise a team of QC inspectors overseeing daily QC inspections activities in compliance with established standards
• Provide training, coaching and mentoring to enhance the skills and performance of team members
• Prepare and maintain work schedule for the department to ensure optimize resource for overall efficiency
• Work with cross-functional teams to implement continuous improvement, track status of non-conformities and CAPA effectiveness
• Responsible for review and approval of DHR. Ensure quality records and samples are retained complying with good writing practice GDP requirements
• Implement quality documentation changes, such as QC procedures, process workflows, work instructions, etc. Guide the team to follow through the change
• Review and submit validation or verification measurement reports
• Perform daily process audit to meet quality operational requirements
• Assist in customer complaint analysis, investigation of quality issues and corresponding improvement measures
• Authorize the release (COC) of products, COA review and approval
• Monitor and report KPI of QC team job performance, production quality trends, quality control charts, etc.

Job Requirements:

• Possess minimum professional certification / Diploma / Degree in relevant subject area
• Working knowledge on ISO13485:2016 and quality assurance / quality control of medical devices is an added advantage
• Familiar with use of various quality control tools and test equipment

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

CSA Execution & Coordination: Support CSA implementation in line with enterprise risk governance standards, identify control gaps in compliance with group policies and regulations, and ensure timely closure of CSA activities.

•Program Enhancement: Support in key risk initiatives, including risk tolerance assessment, thematic reviews, scenario analysis and horizontal review via proactive risk monitoring.

•Stakeholders Engagement: Collaborate with key stakeholders to review and update risk register, control questions and action plans.

•Process Efficiency & Operational Support: Enhance the GRC platform to drive process efficiency. Support R&A operational tasks, including GRC administration and compliance training.

•Documentation & Reporting: Continuous improvement of CSA checklists and reporting templates.

•Training & Support: Provide comprehensive guidance and training on CSA methodology and GRC platform usage, enhance risk awareness, to promote a culture of continuous improvement and proactive risk management (RM).

Qualification & Experience:

•Bachelor’s degree in Accountancy, Information Security, Business Administration, Finance, Economics, or a related field.

•Professional certification (e.g., CRMA, CIA, CISA, CPA, CA) is preferred.

•Possess 6-8 years of experience in a role that involves organisational risk and control management. Skilled in ERM tools, CSA processes, and promoting risk culture initiatives.

Soft Skills:

•Value Creation: Guides stakeholders to elevate performance and fulfill organizational objectives.

•Dynamic: Responds flexibly to emerging risks and changing regulations, ensuring compliance and resilience.

•Collaboration: Showcases exceptional facilitation and presentation skills, engaging effectively with key business stakeholders, risk and control owners and champions.

Technical Skills:

•Methodology: Solid understanding of ERM framework and regulatory compliance, skilled in implementation of ERM and CSA tools, best practices, and support risk culture initiatives.

•GRC Platform: Proficiency in utilizing GRC platforms for ERM, CSA and Controls Continuous Monitoring (CCM).

•Data Analysis (DA): Experience with DA tools such as Python, Excel, Tableau and/ or Power BI for RM, CSA, and CCM dashboard reporting.

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
• Monitor EMO/supplier qualification, assessment and performance evaluation processes.
• Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
• Maintain and update internal audit program.
• Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
• Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
• Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
• Provide training and guidance to quality staff on quality documentation, including system – Veeva (QMS), compliance training system etc.
• Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
• Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times.

The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches.

Responsibilities:

• Ensure that products manufactured meet approved company policies, processes and procedures.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by management.

About You:

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses.
• Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
• Minimum of 3 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Experience in SAP, Trackwise are preferred.
• Ability to quickly know products and processes in order to assess quality issues.
• Committed to quality and maintain a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic.
• Good knowledge of GxP requirements and regulations.
• Good planning and scheduling skills.
• Good communication and interpersonal skills both verbal and written.

Contract Period: 12 months, subject to renewal based on performance.

Based in Tuas.

Job Description

1. Maintain, monitor the implementation & update of relevant audit programs
2. Provide technical advice & support various departments
3. Conduct compliance inspections in production floor & warehouse, identifying key areas for improvements and advice corrective actions
4. Perform QA inspections for incoming/outgoing cargoes based on compliance requirements
5. Coordinate with suppliers to resolve non-conformances
6. Provide in-house training on compliance etc for various departments

Job Requirement

• Diploma in Food Science/Food Technology or related disciplines
• Strong knowledge in food safety, well verse in GMP/GWP
• Strong analytical & problem solving skills
• Excellent interpersonal & communication skills

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

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 Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De