Associate quality manager [medical device] - George Town

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

• Ensure all team members understand and uphold their responsibilities related to patient safety, product quality, and compliance with internal and external regulatory requirements. Maintain up-to-date training across the team.
• Coordinate daily team activities and allocate resources effectively to meet production goals and customer expectations, including managing coverage during holidays and shutdowns.
• Build and maintain a high-performing team by providing coaching, conducting performance appraisals, and aligning individual goals with organizational objectives.
• Exercise independent authority in making decisions related to product quality, including the disposition of non-conforming material. Apply structured problem-solving techniques and sound engineering judgment.
• Lead investigations into manufacturing process defects, customer complaints, and non-conforming products. Drive root cause analysis and implement corrective and preventive actions.
• Oversee the execution and investigation of CAPAs, NCEPs, and failure mode analysis, ensuring timely and effective resolution in accordance with regulatory standards.
• Serve as a leader and subject matter expert in QSR, ISO, MDD, and other applicable standards. Promote best practices and ensure consistent application of quality principles.
• Review and approve test protocols, validation reports, and technical data to establish or update product and process specifications.
• Work closely with EHS to identify environmental impacts and set improvement targets. Collaborate with engineering, suppliers, and other external partners as needed.
• Participate in internal audits and support external inspections, ensuring readiness and compliance across all relevant areas.

• Bachelor’s degree in Engineering, Science, or a related field
• At least 9 years of experience in manufacturing or operational quality, preferably within the medical device industry
• Strong interpersonal, problem-solving, and communication skills, with proven experience in process validation, people management, and team leadership
• Prior involvement in product transfer projects is an added advantage
• skills

• qualifications

• education

Bachelor Degree

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