Quality Assurance Engineer

Welford Manufacturing; Malaysia; On-site; MYR 70,000 - 90,000; Full time

Job summary

A medical device manufacturer in Malaysia is seeking a Quality Assurance (QA) professional to manage quality-related activities and ensure compliance with international standards. The ideal candidate will have a Bachelor's degree in Engineering/Science, at least 4 years of QA/QC experience in medical device manufacturing, and strong communication skills in English and Bahasa Malaysia. Key responsibilities include maintaining quality documentation, tracking product performance, and leading audits. This position offers a dynamic work environment focused on quality improvement.

Qualifications

• 4+ years in QA/QC within medical device manufacturing (infusion sets/IV sets preferred).
• Expertise in ISO 13485, CE Marking, US FDA, Malaysia MDA.
• Experience with audits and root cause analysis.

Responsibilities

• Produce, coordinate, and maintain quality documentation per the Quality Management System (QMS).
• Track product quality and safety performance through reviews and surveillance.
• Perform and coordinate internal/external audits for compliance.

Skills

Strong communication in English & Bahasa Malaysia

Team player with ability to work independently

Computer literate (MS Office, QA software)

Education

Bachelor's degree in Engineering/Science or equivalent

Tools

QMS documentation

ISO 13485

CAPA documentation

Job description

Welford Manufacturing SDN BHD is a manufacturer of high‑quality medical disposable devices, specializing in infusion sets, extension sets, and related products. We are committed to delivering safe, reliable, and innovative medical solutions that meet global regulatory standards.

Job Function

To assist the Quality Assurance (QA) Team in managing and monitoring all quality‑related activities to ensure compliance with international standards and continuous improvement of product quality.

Key Responsibilities

1. Produce, coordinate, and maintain quality documentation per the Quality Management System (QMS).
2. Track product quality and safety performance through periodical reviews and post‑market surveillance, initiating improvement plans.
3. Perform and coordinate internal/external audits to ensure compliance with ISO 13485, MDR, FDA, and Malaysia MDA requirements.
4. Prepare product quality documents for export country registrations.
5. Define and document quality criteria/specifications (incoming, in‑process, outgoing) with QC, Production, Warehouse, and Customers.
6. Ensure QMS compliance by reviewing and revising procedures with cross‑functional teams.
7. Lead root cause analysis for customer complaints and ensure CAPA execution.
8. Support product qualification activities per international/local standards.
9. Assist in developing QA departmental goals and improvement plans.
10. Prepare departmental reports and support the QA Team as needed.
11. Provide training on product quality and safety standards.

Job Interfaces

Collaborate closely with Production, Sales & Marketing, Warehouse, and Purchasing to enhance product quality.

Job Authorities

Assist the QA Team in departmental duties and quality/safety training.

General Requirements

• Ensure QMS compliance with ISO 13485 & MDR at all times.
• Promote Health, Safety, and Environmental (HSE) awareness within the team.

Job Requirements

Education & Experience

• Bachelor's degree in Engineering/Science or equivalent.
• 4+ years in QA/QC within medical device manufacturing (infusion sets/IV sets preferred).

Technical Skills

• Expertise in ISO 13485, CE Marking, US FDA, Malaysia MDA.
• Experience with audits, CAPA, root cause analysis, and QMS documentation.

Soft Skills

• Strong communication (English & Bahasa Malaysia).
• Team player with ability to work independently under pressure.
• Computer literate (MS Office, QA software).