Quality Engineer — MedTech Process & Compliance

Becton Dickinson; Kulim; On-site; MYR 60,000 - 120,000; Full time

Job summary

BD is seeking a Quality Assurance professional to support new product launches and ongoing production in Kulim, Malaysia. You will develop quality plans, validation protocols and inspection methods, and lead investigations into customer complaints.

The role requires fluency in Bahasa Malaysia and English, and experience in the medical device field. You will contribute to continuous improvement and regulatory compliance while collaborating across teams.

Qualifications

• Experience in the medical device or pharmaceutical industry.
• Practice in the use of root cause analysis tools.
• Application of statistical techniques.

Responsibilities

• Support the implementation of new products and ongoing production by developing and maintaining quality plans, validation plans, inspection methods and work instructions.
• Investigate, document, perform root cause analysis and implement corrective actions for customer complaints.
• Compile, analyze and interpret inspection, process and product data to identify quality problems and continuous improvement opportunities.
• Lead change control and risk management processes; participate in internal and supplier audits as needed.
• Communicate across functions/departments and support regulatory and customer audits.

Skills

Root cause analysis

Analytical thinking

Teamwork

Education

Bachelor's degree or equivalent

Job description

BD is seeking a Quality Assurance professional to support new product launches and ongoing production in Kulim, Malaysia. You will develop quality plans, validation protocols and inspection methods, and lead investigations into customer complaints.

The role requires fluency in Bahasa Malaysia and English, and experience in the medical device field. You will contribute to continuous improvement and regulatory compliance while collaborating across teams.