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Sr Mfg Operations QA Manager

Medtronic

Medtronic

Operations, Quality Assurance
Kulim, Kedah, Malaysia
Posted on Mar 18, 2026

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 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.


Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here