Quality Engineer, Medical Devices - Data-Driven GMP Expert

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

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.