Sr Mfg Operations QA Manager

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life—a commitment that provides life-transforming technologies that treat more than 70 health conditions across cardiovascular, neuroscience, and surgical care. In 2025 our products and therapies treated more than 75M people — that’s two people every second of every hour, of every day. Together, we can change healthcare worldwide which is why we’re embarking on a new venture in Malaysia and want you to be a part the next generation of life-changing medical technology to patients worldwide by being a part of our next chapter of innovation in Malaysia. Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting commitment to our new venture in Malaysia. Summary Leads the development and deployment of the Quality Systems Ensures products manufactured meet all defined specifications and comply with applicable quality system requirements. Drives excellence in product quality, operational performance, and a culture of putting patients first. Key Accountabilities 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. Attributes 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. Experience, Knowledge and Qualifications Bachelor’s degree with at least 7 years of relevant experience, including 5 years ... (truncated, view full listing at source)