Quality manager [medical device] - Bukit Mertajam

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

• 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.

• 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.
• skills

• qualifications

• education

Bachelor Degree

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