Sr Mfg Operations QA Manager
Share
Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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. Were purposeful. Were committed. And were driven by our Mission to alleviate pain restore health and extend lifea commitment that provides life-transforming technologies that treat more than 70 health conditions across cardiovascular neuroscience and surgical 2025 our products and therapies treated more than 75M people thats two people every second of every hour of every day.Together we can change healthcare worldwide which is why were 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 worlds 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
- Bachelors 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.
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 95000 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
Required Experience:
Manager
Key Skills
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
