Quality Engineer [Medical Device]

Randstad Malaysia; Perak; On-site; MYR 50,000 - 80,000; Full time

Job summary

Randstad Malaysia is seeking a Quality Engineer to join a global medical device manufacturer. This role involves leading quality planning, overseeing inspections, and ensuring compliance with GMP. Candidates should have a Bachelor's degree in Science or Engineering and a minimum of 2 years of experience in quality, preferably within the medical devices sector.

The position offers a fast-paced environment with opportunities for career growth and professional development.

Qualifications

• Minimum 2 years of quality experience, preferably in medical device manufacturing.
• Familiarity with cleaning validation and inspection documentation.
• Ability to conduct statistical analysis on quality performance metrics.

Responsibilities

• Lead quality planning for new projects and author inspection specifications.
• Oversee inspections and ensure compliance with GMP.
• Conduct audits and facilitate investigations of quality incidents.

Skills

Quality tools (Seven QC Tools, Five Core Tools)

Minitab for data-driven improvements

Mandarin proficiency

Education

Bachelor Degree in Science, Engineering, or related field

Job description

About the job

Our client is a global medical device manufacturer leading the charge in healthcare innovation. They offer a fast-paced, high-tech environment with structured career pathways designed to accelerate professional growth for ambitious Quality Engineers obsessed with precision and excellence.

Responsibilities

• Lead quality planning for new projects, establish product line control plans, and author inspection specifications for raw materials, in-process production, and finished goods.
• Oversee in-process and finished product inspections, conduct compliance reviews of batch records, and ensure the accuracy, traceability, and archiving of Device History Records (DHR).
• Manage non-conforming or detained products efficiently and conduct regular cleanroom audits to drive strict GMP compliance.
• Facilitate cross-departmental meetings to investigate quality incidents, adverse events, and customer complaints using root cause analysis to track NCR and CAPA closures.
• Perform regular statistical analysis on product line quality performance metrics to identify trends and propose data-driven continuous improvement initiatives.
• Support internal and external regulatory/customer audits, while training QC personnel on inspection standards, equipment operation, and general quality awareness.

Experience

• Degree or higher in Science, Engineering, or a related field.
• Minimum 2 years of quality experience, preferably within medical device manufacturing.
• Familiar with cleaning validation, cleanroom control, inspection documentation, and batch record reviews.
• Skilled in quality tools (Seven QC Tools, Five Core Tools) and Minitab for data-driven improvements.
• Mandarin proficiency is preferred to facilitate effective stakeholder communication.

Skills

No additional skills required.

Qualifications

No additional qualifications required.

Education

Bachelor Degree