Quality Manager [Medical device]

Randstad Malaysia; George Town; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading player in the Medical Device Manufacturing Industry is looking for a Quality Manager in Penang. This role involves leading a high-performing Quality Engineering team and ensuring product compliance with standards. The ideal candidate has over 10 years of experience in medical device production, with strong leadership and quality management skills. Attractive remuneration and benefits package included.

Benefits

Attractive remuneration and benefits package

Qualifications

• At least 10 years of experience in a medical device production environment.
• Minimum of 3 years leading a team.
• In-depth knowledge of ISO 13485 and 21 CFR 820 regulatory requirements.

Responsibilities

• Leads and develops a high-performing Quality Engineering team.
• Participates in customer complaint investigations.
• Champs continuous improvement in quality initiatives.

Skills

People management

Problem-solving

Risk management

Deviation/excursion handling

Statistical methods

Education

Bachelor of Science in Biomedical Science, Engineering, or a related field

Job description

We are currently looking for a Quality Manager for a leading player in the Medical Device Manufacturing Industry with a legacy of more than 40 years in the world. This position requires your urgent attention.

• Reporting to: Quality Director
• Based in Penang
• Attractive remuneration and benefits package

the job

• Leads and develops a high-performing Quality Engineering team, ensuring alignment with customer needs, compliance standards, product quality goals, and risk mitigation strategies.
• Holds independent decision-making authority for product quality matters, including the disposition of non-conforming products.
• Drives functional and technical excellence, managing or supporting quality deliverables across product and process development initiatives.
• Participates in customer complaint investigations, ensuring timely and thorough resolution within their area of responsibility.
• Acts as a subject matter expert in QSR, ISO, and MDD standards, guiding quality-related decisions and promoting best industry practices.
• Leads quality planning and execution for major segments of complex projects, ensuring regulatory and organizational requirements are met.
• Approves and reviews validation, test, and operational data to define technical specifications and ensure consistent product performance.
• Champions continuous improvement by implementing new quality initiatives and enhancing the Quality Management System at the site and corporate levels.
• Mentors and develops staff, facilitating the adoption and understanding of quality initiatives and fostering a motivated, high-performance team culture.
• Collaborates cross-functionally on budget planning, EHS initiatives, and internal audits to support regulatory compliance and sustainability goals.

the experience

• Bachelor of Science in Biomedical Science, Engineering, or a related field, or equivalent degree.
• At least 10 years of experience in a medical device production environment, including a minimum of 3 years leading a team.
• In-depth knowledge of ISO 13485 and 21 CFR 820 regulatory requirements.
• Strong skills in people management, problem-solving, risk management, and deviation/excursion handling.
• Familiarity with statistical methods and a basic understanding of financial principles is a plus.