Sr Mfg Operations QA Manager

• Build the quality team and function at the manufacturing site: define structure, hire key talent, establish roles and responsibilities, and set up quality processes.
• Lead and oversee the development and maintenance of quality programs, systems, and procedures to ensure compliance with internal and external standards.
• Provide expertise in interpreting regulatory and internal policies to ensure compliance.
• Establish quality initiatives to support product development and manufacturing in accordance with applicable requirements, including strategic programs like new product introduction, product transfer, and technology implementation.
• Support engineering projects and provide oversight in establishing quality system requirements at other facilities and projects.
• Lead audit and inspection preparation, manage resolution of findings, and liaise with auditing bodies throughout the audit process.
• Serve as the management representative for the manufacturing site and act as the point of contact for regulatory queries related to quality systems and operations.
• Facilitate standardization and best practice sharing
• Develop, evaluate, and maintain technical quality assurance and control systems related to materials, techniques, or products.
• Coordinate with external suppliers and consultants to ensure timely delivery.
• Influence leaders across multiple teams and functions.
• Support and participate in new product introduction, product transfer, and technology implementation, which may require travel to other countries.

• Autonomy: Manages a large team of professionals and managers. Translates strategy into actionable business plans. Operates with significant latitude.
• Organizational Impact: Initiates programs based on business needs. Decisions affect deadlines, resources, and organizational goals. May hold budget or P&L accountability.
• Innovation and Complexity: Develops new objectives, policies, and standards. Tackles complex, undefined problems requiring deep analysis.
• Communication and Influence: Engages with internal and external stakeholders. Influences across functions and balances divergent objectives.
• Leadership and Talent Management: Manages departments or functions with other managers and professionals. Recommends strategies and authorizes key personnel decisions.

• Bachelor’s degree with at least 7 years of relevant experience, including 5+ years in a managerial role; or
• Advanced degree with at least 5 years of relevant experience, including 5+ years in a managerial role.
• Effective bilingual communication skills (English and Malay).
• Experience in pharmaceutical, medical devices, or other highly regulated manufacturing industries.
• Strong operational and financial acumen; business and project management experience is a plus.
• Familiarity with Quality System Regulations (FDA), ISO standards, and EU MDR.
• Proven leadership in manufacturing environments and global quality functions.

Medtronic