949 Medical Quality Assurance jobs in Singapore

Quality Assurance Specialist Medical Device Industry

Roles & Responsibilities:

• Develop and implement product inspection processes, ensuring compliance with regulatory requirements.
• Maintain labeling compliance for country-specific markets.
• Implement and track quality holds in 3PL facilities to ensure timely resolution.
• Drive improvement initiatives for 3PL quality management systems, including quality agreements.
• Execute rework activities efficiently to minimize downtime.
• Initiate and track internal complaints related to labeling and regulatory non-compliance.
• Perform first article inspections (FAI) for products distributed in Asia Pacific and Greater China regions.
• Ensure implementation of company procedures/work instructions in the warehouse.
• Manage SCARs and follow up on their resolution.
• Act as a quality engineer for Asia Pacific labeling and other quality documentation.
• Seller Management
• Maintain existing supplier relationships and support new supplier qualification.
• Provide quality training to suppliers.
• Implement Supplier Control Process.

Post Market Quality Assurance:

• Oversight and maintain compliance of Product Complaint Handling Process in APAC, including receiving and reporting complaints to CH Center.
• Execute Field Corrective Action Process, including operations in JDE system. Act as Local FCA Coordinator for Region.
• Generate quality system reports and perform trend analysis.
• Maintain training compliance for region.
• Participate on audit teams by responding and gathering data to address audit requests.
• Own and manage NCR, CAPA, PRA in region.
• Assess the impact of quality systems information (e.g., Enterprise Change Requests (ECRs), CAPA) and provide feedback to originators.

Requirements:

• Bachelor's degree in a related field.
• 3 years of previous experience in quality and/or manufacturing environment in the medical device industry.

As a quality assurance professional, you will play a critical role in ensuring the compliance and excellence of medical devices across the Asia Pacific region.

Key responsibilities include implementing product inspection processes, managing quality holds, driving improvements in 3PL quality management systems, acting as a quality engineer for Asia Pacific labeling, supplier management, and post-market quality assurance.

This role requires strong analytical skills, excellent communication abilities, and the capacity to manage competing priorities in a fast-paced environment. To be successful, you should have a degree in a relevant field and at least 3 years of experience in quality and/or manufacturing environments in the medical device industry.

Familiarity with medical or pharmaceutical regulations and a strong understanding of medical devices regulations such as ISO13485 are essential for this position.

Joining our organization offers an exciting opportunity to work with a team that prioritizes quality and customer satisfaction. If you are a motivated and organized individual passionate about quality, we encourage you to apply.

Duties & Responsibilities:

• Maintain and upkeep production/training/safety-related documentation.
• Maintain and upkeep receiving records/documents and request COAs from vendors.
• Coordinate with QA/QC department to ensure operation complies with food safety (e.g., FSSC/ISO) and all regulatory requirements (e.g., SFA).
• Ensure the retention samples arrangement, e.g., get from production, retention area arrangement, arrange to an external laboratory, and submit the analysis to QA for review.
• Assist in ensuring the products are traceable.
• Ensure production efficiency with minimal wastage.
• Assist in monthly pest control services.
• conduct daily inspection on receiving on raw materials, production, deliveries regulatory requirement add Halal
• Asist in food safety internal audit, customer audit, FSSC/ISO audit.
• Supporting in any ad-hoc duties as assigned by management from time to time.

Requirements:

• Minimum Diploma in Applied Science (Nutrition and Food Science) or related fields
• Basic food hygiene certification is an added advantage
• Minimum 1-year relevant working experience in food manufacturing
• Good interpersonal and communication abilities.
• Proficient in MS office e.g., Word, and Excel.

Working Hours:

• Monday to Friday – 8.30 am to 5.30 pm
• Saturday – 8.30 am to 12.00 pm

Transport provided from Kranji MRT Station

Lunch is provided in-house.

-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

Responsibilities:

· Direct and Supervise WIP and Final Inspections

· Handle and Approve First Article Submissions

· Understand & Ensure Compliance with customer’s requirements

· Monitor, maintain and continually improve quality standards.

· Resolve Quality issues with internal and external parties.

· Supervise and maintain calibration of measuring equipment

· Review on non-conformances & approve disposition actions.

· Create 8D reports.

· Provide periodical quality review and trainings

· Involve in First Article Product and process development

· Assist in maintaining ISO System, reports, follow-up and closure

Requirements:

· Minimum Diploma in Mechanical/ Manufacturing or related Engineering field.

· Minimum 5 years in related field.

· Knowledge on measuring and statistical techniques

· Knowledge on CMM Machine

· Responsible, Positive Attitude and able to work well as a team.

· Able to lead a team of quality operators

· Able to work in Tuas area

· Class 3 license is an advantage

If you are interested to join our enriching and challenging environment, please submit a comprehensive resume to: to include:

1. Recent passport-sized photo

2. Current Salary

3. Expected Salary

4. Notive Period

Working Location: Near Kranji

Responsibilities:

-Maintain and upkeep production/training/safety-related documentation.

-Maintain and upkeep receiving records/documents and request COAs from vendors.

-Coordinate with QA/QC department to ensure operation complies with food safety (e.g., FSSC/ISO) and all regulatory requirements (e.g., SFA).

Ensure the retention samples arrangement, e.g., get from production, retention area arrangement, arrange to an external laboratory, and submit the analysis to QA for review.

-Assist in ensuring the products are traceable.

-Ensure production efficiency with minimal wastage.

-Assist in monthly pest control services.

-conduct daily inspection on receiving on raw materials, production, deliveries regulatory requirement add Halal

-Asist in food safety internal audit, customer audit, FSSC/ISO audit.

-Supporting in any ad-hoc duties as assigned by management from time to time.

Requirements:

-Minimum Diploma in Applied Science (Nutrition and Food Science) or related fields

-Basic food hygiene certification is an added advantage

-Minimum 1-year relevant working experience in food manufacturing sector

-Proficient in MS office e.g., Word, and Excel.

Remuneration:

-Basic Salary :$2500-4500 (depending on working experience)

-Working Hours: 8.30AM-5.30PM (Mon to Fri) 8.30AM-12.00PM(Sat)

-Company Transport provided from Kranji Mrt

-Lunch Provided

-5.5 days work weeks

-Entitled to annual leave and medical leave benefits

• Well Established Company
• Basic $2500 - $3300 + OT + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working Location : East
• Working hours : 5 working days (8am to 5pm)

Job Responsibilities:

• Conduct detailed inspections of finished products to identify defects, non-conformities, and deviations from quality standards
• Support quality in handling defective found during the production
• Collaborate with the quality control team to resolve material quality issues and determine disposition (accept, reject, or rework)
• Collaborate with the production, quality teams to identify root causes of defects and non-conformities
• Perform First Article (FA) report and propose process improvements
• Collect parts for 2 hourly to visual inspection
• Key in data
• Other ad-hoc duties as assigned

Job Requirements:

• Minimum GCE ‘O’ Level / Nitec / Diploma in Quality Assurance or equivalent with 1-2 years of related work experience
• Able to use Smart Scope, Keyence, Micrometer & others measuring equipment
• Able to interpret 2D drawings

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 Company
• Basic $2500 - $3300 + OT + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working Location : East
• Working hours : 5 working days (8am to 5pm)

Job Responsibilities:

• Conduct detailed inspections of finished products to identify defects, non-conformities, and deviations from quality standards
• Support quality in handling defective found during the production
• Collaborate with the quality control team to resolve material quality issues and determine disposition (accept, reject, or rework)
• Collaborate with the production, quality teams to identify root causes of defects and non-conformities
• Perform First Article (FA) report and propose process improvements
• Collect parts for 2 hourly to visual inspection
• Key in data
• Other ad-hoc duties as assigned

Job Requirements:

• Minimum GCE ‘O’ Level / Nitec / Diploma in Quality Assurance or equivalent with 1-2 years of related work experience
• Able to use Smart Scope, Keyence, Micrometer & others measuring equipment
• Able to interpret 2D drawings

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