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.
