• Facilitates planning and development ofquality control systems for specifiedproducts or processes.
• Collaborates with teams of engineers andproduct specialists to ensure customer anddivision quality requirements are met.
• Identifies the root cause of qualityproblems, and coordinates modificationsor other corrective actions.
• Liaising of Calibration Program.
• Periodically inspect instrument accordingto the specified schedule date
• Reviews design, manufacturing, and testingdocumentation.
• Update our Quality Management system(QMS) with incidents, fixes andimprovement.
• Offers technical guidance and support inresponse to quality testing and analysis.
• Ensures contract compliance by reviewingand approving quality requirements forsupplier purchase orders, manufacturing,and other related services.
• Performs other duties as assigned.

Job Description

1. Supervise a team of QC Officers in all factories.
2. Guide and troubleshoot for any equipment issues, co-ordinate with external service providers Ensure laboratory equipment is calibrated in a timely manner and update calibration records. Assist to keep, control, and confirm formulation and blending procedures.
3. Respond to new and existing customers for inquiries related to quality control Conduct quality testing and communicate product specification issues. Conduct nonconforming material or nonconforming product analysis.
4. Participate in the root cause analysis of nonconforming goods.
5. Follow the instructed corrective actions and preventive actions by superiors. Establish formulation and blending procedures as needed.
6. Keep and monitor retain samples of products
7. Validate COA of raw materials received and communicate any issues to the procurement and Plant Manager Establish, update and issue GHS SDS.
8. Create certificate of analysis (COA) of products.
9. Confirm and provide resources for the laboratory and other QCR needs.
10. Coordinate sample delivery as required by the customer.

Job Requirements

• Min. Degree in Chemistry related field or
• Diploma in Chemistry with minimm 5 years of relevant experience
• Technical Knowledge : Microsoft Officer (Basic) / Good knowledge & skills on QC testing
• Ability to coach and mentor the team

Job Description..

• Ensure all packing workers are performed their jobs according to the written work instructions.
• To place packaging materials from the store by based on the packing plan.
• Verify and monitor the work done by Group Leaders and Inspectors.
• To handle and follow up on the problems forwarded by Group Leaders.
• Checked and reviewed all checklist and reports by Group Leader and below by timely basis.
• Assist final packing area.
• To provide on the job training to the Packers, Inspectors, Group Leaders other support operators.
• To ensure packing procedure and packing method are implemented and practiced.
• Ensure storage, packaging, online and final packing area are clean and tidy at all times.
• Ensure the product is stored, labeled and segregated at designated area.
• Ensure worker is handle products in correct manner and not causing any damage or contamination onto the products.
• Inform to Executive/Engineer or Manager for any equipment need to be repair, service or calibrate.
• To conduct appraisal for the worker during probationer period.
• Any other task that may be assigned.
• Help packing at warehouse.
• Performance the QAQC task in the warehouse.
• Paying attention to detail, especially when it come to quality control.

Job Description

To perform inspection by using CMM & other measuring equipments

To ensure parts are according to customer's requirements

Job Requirements

Higher NITEC level in technical engineering or GCE 'O' level

Minimum 1 year related working experiences

Able to operate CMM machine independently is an advantage

Able to commit overtime

Good team player

Independent

In this role, you will:

• Job shadow / On-job training with the team to understand cable manufacturing and testing process
• Be involved in QC tests (Incoming Quality Control, In-Process Quality Control, Final Quality Control/Out-going Quality Control)
• Prepare technical reports based on customer’s required specification
• Develop and implement performance improvement and quality assurance programs
• Be closely involved in one or two projects relating to QC team’s productivity or digitalization efforts

Job requirements:

• Strong attentiveness to details as QC data requires accuracy
• Takes initiative in leading a task and will proactively check in when in doubt
• Basic knowledge in quality assurance or systems and/ or process optimization is a plus
• Proficient in MS Office (Excel, Powerpoint)
• Comfortable in working with data

*Kindly indicate the period you are able to commit to the internship in resume

*Only available for internship period beyond August

Work Location - Near Aljunied MRT

5 days work week

Roles & Responsibilities

This position is responsible for conducting audit checks to ensure that products meet the established standards, This role also supports the achievement of Company quality target.

1. Confirm to quality standard and quality processes

· Inspect in-coming and outgoing products according to policies standard.

· Perform all product processes within section (eg, QC, SAO), Reworks, Repairs, Defective photo-taking)

2. Contribute to continuous improvement

· Maintain Integrity accuracy and completeness of Supplier invoice data and QC data in system

· Establish standard operating procedures and conditions for handling storage and checklist of stock.

3. Perform other ad-hoc duties as assigned.

Requirements

· At least 1 year of experience in Gold quality control in retail jewellery or quality control experience in manufacturing

· Those with more years of experiences will be considered for the senior executive position

· At least Diploma in any discipline

· Basic understanding of production methods.

· Attention to detail

· Able to use basic MS Office.

· Good Communication and Interpersonal Skills

· Able to multi-task and quick learner

Your Role

• Perform checks on the structural, architectural and M&E materials/works to ensure that the final touch-up works are ready for inspections
• Monitor the performance of subcontractor workers for all trades and ensure any defects are properly rectified
• To participate, work closely and give support to safety personnel at site on all initiatives/ matters relating to Safety and Health
• To comply with the Company Safety Management System and the WSHA and its subsidiary legislation

The Requirements

• Possess a Degree in Civil Engineering or its equivalent
• Minimum 3-5 years of relevant working experience in construction industry
• Must be technically inclined and possesses excellent problem-solving
• Be able to work independently as well as acquiring good interpersonal skills to coordinate between the various disciplines and construction teams

• Possess knowledge in GMP and halal certification processes
• Assist in GMP preparation for audit
• Assist QC manager in daily operations
• Testing of finished products against specifications and to notify for any out of specifications
• Maintenance of manufacturing facility as per GMP requirements
• Prepare products for testing from external laboratories
• Conduct instrument analysis and calibration of laboratory equipment and basic equipment maintenance
• Assist in generation of Certificate of Analysis
• Conduct incoming materials check

Requirements

• Minimum Diploma in Chemistry or relevant courses
• Minimum 2 years of experience
• Able to work independently with minimal supervision
• Able to write and communicate in English
• Knowledge in Excel and word
• Knowledge in SAP will be an added advantage

Job Description

• Lead and guide sub-contractor to achieve quality workmanship
• Handle paperworks , defects issuance and reporting
• Conduct defects investigation and identification

Requirement

• Minimum 4 years in CONQUAS
• Possess at least 2 good industry practices certificates
• Microsoft office knowledge
• Able to communicate with client and consultant

Responsibilities

a) Manage asphalt premix production quality control processes;
b) Conduct regular inspections and testing;
c) Analyse test results and implement corrective actions;
d) Maintain quality control records and documentation;
e) Train production staff on quality control procedures;
f) Collaborate with production and laboratory teams;
g) Develop and implement quality improvement initiatives;
h) Under the WSH Act, employees have a duty to keep their workplace and colleagues safe:
• Cooperate with employers and follow safety and health procedure;
• Report unsafe acts and incidents;
• Do not tamper with safety devices or perform wilful or reckless acts; and

i) Be responsible for any other duties that may be assigned to you from time to time as your superior / management deem fit.

Requirement

• Diploma / Certificate in Asphalt Technology or related fields
• Preferably with relevant experiences
• Well knowledge in quality control procedures and standards (ASTM, AASHTO, BS)
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to interpret test results and make informed decisions
• Familiarity with quality management systems (ISO 9001)
• Proficient in Microsoft Office and laboratory software

We are looking for a Quality Control Assistant to support the Quality Assurance Executive in maintaining the highest standard of product quality and safety.

Job Description:

• Responsible for FSMS (GMP, HACCP, ISO 22000, HALAL) monitoring
• Consistent monitoring of quality and specification of product during processing
• Perform inspection for incoming material and outgoing finished product
• Recording and maintaining data for QC information
• Collect samples for product testing
• Report to the department lead on nonconforming products or processes detected

Requirement:

• Physically fit to work in cold room environments with the ability to stand and walk for extended periods.
• WSQ Food Safety Course Level 1 and/or Level 3 certification preferred, familiarity with food/seafood handling and processing is a plus.
• Meticulous with strong organizational and communication skills.
• Strong communication, organizational skills, and ability to walk and stand in a fast-paced cold working environment.
• Proficient in English and Mandarin to interact with Mandarin/English-speaking stakeholders.
• Willing to take up ad-hoc duties assigned by the company.
• Knowledge of SAP will be advantageous.

Job Highlights

• Job Types: Permanent/Contract
• Working Hours: Mon to Fri 7.45 am to 4.45 pm, alternate Sat
• Great learning development opportunities.
• Work-life balance and positive/friendly working environment.

About the role

To support R&D department in conducting laboratory tests, sample preparation and executing technical and quality control documentation/testing while co-ordinating with various departments to ensure smooth running of the organisation.

Roles & Responsibilities

Sample Preparation

• Receive and label all raw materials brought into the lab for accountability.
• Maintain inventory of chemicals.
• Prepare materials for experiment and assist R&D activities..
• Assist R&D Engineer to conduct experiments and operate equipment.
• Assist in the procurement and placement of all consumables, equipment and fixtures.
• 
  

Measurement & Calibration

• Perform periodic calibration of equipment and reporting of any malfunctions.
• Assist in troubleshooting and maintenance of all testing equipment.
• Ensure proper housekeeping of laboratory on a daily basis.
• Maintain and record equipment faults.
• Troubleshooting of analysis methods.

Perform Laboratory Data Analysis and Reporting

• Recording and reporting of experimental results and trends.

Quality Control

• Perform in process quality check and physical test on in-process materials & finished products
• Testing of properties of aerogel products and co-ordinating with 3rd party laboratories.
• Prepare QC documents for all batches in production department

Compliance with Safety Protocols and Local Regulatory

• Assist with the application and maintenance of all necessary governmental licenses related to the laboratory.
• Assist workplace safety initiatives.
• Implement and manage waste disposal and coordinate with chemical disposal companies.

Requirements

• ITE / Diploma in Chemical Engineering, Chemistry, Biotech, Lifesciences and Pharma etc.
• Years of work experience: At least 1 - 3 years.
• Training will be provided.
• Knowledge of safe handling of chemicals
• Possess basic computer skills and Microsoft Office applications.
• Team player and able to work independently

To apply:

You can apply directly by sending your cover letter and resume directly to [email protected] quoting ‘Qua_Ctrl in the subject line. In the CV/resume, outline why you would be the best fit for this job, date of availability, details of your educational background and work experience.

In this role, you will:

• Engage in one or more projects to boost QC team productivity or digitalization, tailored to your interests and strengths.
• Job shadow and on-the-job training with the QC team to understand cable manufacturing and testing processes.
• Prepare technical reports per customer specifications, documenting data from QC inspections and tests.
• Perform daily tasks including inspections, data entry, report preparation, and other ad hoc duties.
• Assist in QC tests.

Job requirements:

• Basic knowledge in quality assurance or systems and/or process optimization is a plus.
• Skilled in MS Office (Excel, PowerPoint) and practical, hands-on tasks.
• Receptive to feedback and keen to learn from experiences.
• Lead tasks proactively and seek clarification when needed.
• Comfortable working with data.

*Kindly indicate the period you are able to commit to the internship in resume

*Only available for internship period beyond January 2025

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Quality Control Analyst with experience in pharmaceutical company/Life Science industries for a role in Singapore.

Key Responsibilities:

• Sample storage and management
• Prepare and support analytical testing
• Analytical testing and documentation
• Perform lab housekeeping activities
• Perform administrative documentation
• Comply with all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Responsible for participating in initial training and retraining

Qualifications:

• Proficient in English.
• Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production).
• Nitec or Diploma holders

This position is for permanent 12-hr night shift, 2-3-2 basis.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

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

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

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.

NG JYA YEE (R23119014)

EA Recruitment Pte Ltd

EA License No: 21C0492

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

• Ensure all quality control documentation is compiled and completed for as-built handover through the QC turnover engineer
• Review and prepare reports on Authority inspections (RI inspection, BCA TOP inspection, etc)
• Establish Project Quality System, implement and maintain in accordance with Singapore standards application to BCA for CONQUAS Assessment and provide a framework to achieve the score
• Assess the implementation of the Quality Plan and Quality Control Plans on site
• Ensure the project QA/QC plan follows specifications and contract requirements
• Compete for site quality control instructions and action remedial responses
• Coordinate quality inspections with all the site subcontractors and vendors and coordinate all non-destructive testing on site
• Distribute relevant QA/QC documentation to site subcontractors
• Verify the quality-related site activities are in accordance with the applicable codes and standards
• Participate in the site's internal and external site audits
• Coordinate all the quality site inspections through the site QC inspectors
• Control all nonconformance reports and undertake remedial action
• Must have fluent English communication skills to liaise with the Client’s staff
• Have Main Contractor Experience

General Responsibilities

• Ensure that all services provided by the centres meet or exceed internal standards and quality assurance guidelines.
• Conduct audits to ensure regulatory compliance, reviewing internal processes and procedures, and identifying high-risk non-compliance areas in line with regulatory standards.
• Participate in initiatives aimed at improving the quality of early childhood care and education at the centres.
• Ensure adherence to corporate identity and guidelines across all centres.
• Ensure that the team provides a safe, nurturing environment that fosters children's social, emotional, physical, and intellectual development.
• Promptly escalate any issues or concerns to management.

Licensing and SPARK Certification

• Familiarity with the ECDC Act.
• Familiar with the SPARK QRS-U framework.
• Ensure that all centres comply with regulatory standards.
• Develop action plans to meet Licensing and SPARKS criteria.

Policies and Procedures

• Oversee, track, and monitor the centres' corrective action plans, ensuring that principals, supervisors, and staff follow through and assess the effectiveness of these actions.
• Motivate the team to achieve operational efficiency, maintaining organizational capabilities without compromising quality standards.

Requirements:

• Diploma in Early Childhood Care & Education (ECCE) or a related discipline.
• Minimum 3 years of relevant experience in the field.
• Knowledge of quality/compliance management and early childhood regulations and standards.
• Experience with quality improvement systems.
• Strong analytical skills, attention to detail, and ability to review data effectively.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Preferably a Junior Executive specializing in Quality Control/Assurance or a related role.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No. 20C0270

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

• 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.

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

Key Responsibilities

The successful incumbent will support the QA Manager in the following responsibilities.

• Ensure compliance with the Company’s food safety management system, QA standards, customer requirements, certification audits, and regulations for quality and food safety control processes.
• Support the Quality Assurance Manager (QAM) in preparing external and internal audits according to customer standards/contract requirements, and drive cross-functional teams to achieve targeted performance.
• Conduct site inspections to promote continuous improvement and adherence to Standard Operating Procedures (SOPs), hygiene, and food safety practices.
• Manage QA random sampling and microbiological testing for food samples, raw materials, water & ice, hand swabs, and Environmental Monitoring Program (EMP).
• Analyze data and follow up on unsatisfactory test results to identify potential causes of failure, recommend corrective actions for process improvement, and prevent recurrence.
• Prepare documentation related to all export matters in the capacity of Quality Person (QP).
• Develop training materials and conduct food safety trainings for operational staff.
• Review new product artwork to ensure regulatory compliance.
• Assist QAM in food safety incident management, including site investigations, testing, and preparation of incident reports.
• Support QAM in maintaining the ISO 22000/HACCP manual and QA documentation.
• Assist in the supplier approval program (supplier assessment/documentation review).
• Contribute to QA work plans and initiatives aimed at improving QA processes and food safety standards.
• Support Group QA, annual emergency exercises, and ad-hoc catering events as required.

Key Requirements

• Minimum Degree in Food Science/ Technology or other relevant fields.
• Minimum 2 year of QA experience in the food industry.
• Passionate in upholding food safety and possess good knowledge of Food Regulations, SFA requirements, GMP, and food safety management certifications (e.g., HACCP, ISO 22000, GFSI standards).
• Keen learning attitude, proactive, and decisive.
• Detail-oriented and meticulous with competency in report writing and presentation skills.
• Independent, committed and possess strong interpersonal communication skills
• Ability to multi task, handle stress in a fast-paced environment, and meet tight deadlines.
• Excellent interpersonal and communication skills.
• Collaborative and able to work effectively in a team.
• Must be comfortable working in a cold environment.

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.

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