Senior Quality Engineer — Global Manufacturing Transfer Leader

AMS; Kulim; On-site; MYR 70,000 - 90,000; Full time

Job summary

A global leader in quality engineered solutions seeks a Senior Quality Engineer to drive manufacturing process transfers at their new facility in Kulim, Malaysia. Responsibilities include ensuring compliance with ISO 13485 standards, mentoring junior engineers, and collaborating with cross-functional teams. The role requires a degree in engineering and at least 4 years of experience in regulated industries. Candidates must have strong communication skills and be willing to travel internationally. This position is fully on-site with potential remote collaboration.

Qualifications

• Minimum 4 years of relevant experience in regulated industries, or advanced degree with 0 years of experience.
• Proficient in preparing and reviewing technical documentation.
• Ability to communicate clearly in verbal and written forms.

Responsibilities

• Guide and mentor junior quality engineers and team during transfer.
• Develop and maintain quality standards complying with ISO 13485.
• Collaborate with teams to integrate quality requirements into transfer plans.

Skills

Technical documentation preparation

Communication skills

GMP knowledge

ISO 13485 knowledge

Problem-solving

Cross-functional collaboration

Education

University degree in engineering (biomedical, chemical, industrial, biotechnology)

Job description

A global leader in quality engineered solutions seeks a Senior Quality Engineer to drive manufacturing process transfers at their new facility in Kulim, Malaysia. Responsibilities include ensuring compliance with ISO 13485 standards, mentoring junior engineers, and collaborating with cross-functional teams. The role requires a degree in engineering and at least 4 years of experience in regulated industries. Candidates must have strong communication skills and be willing to travel internationally. This position is fully on-site with potential remote collaboration.