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

Responsibilities may include the following and other duties may be assigned:

• Supporting the Articulating Technologies QMS. Working as a pragmatic partner with the organization to ensure QMS processes related to General QMS & Pilot production are established implemented and maintained in a compliant manner
• Quality mentor for process development & production processes amongst others responsible for support of process development (IQ OQ PQ) & related equipment development Quality aspects. Production Quality aspects like supporting improvement is production related processes NCP support stand-ups Quality control meeting
• Establish & maintain the pilot production line Quality aspects in Geleen & leading the Q aspects of transferring of the pilot production line to a receiving site
• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements and supports the EU OU Surgical entities from a Quality Oversight perspective consisting of pro-active support (example helping supporting entities with setting up QMS processes audits & certifications) & re-active support related to production quality issue resolution PHO and FCA support)
• Coordination and/or preparation of internal and external audits in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities) for the Operating Unit
• Owns and drives Nonconform product Investigations Root Cause Analysis and resultant Corrective Actions and Preventive Actions performs trend analyses and report compliance observations to identify areas in need of improvement and investigates and resolves compliance problems questions or complaints received from other units of the company customers government regulatory agencies etc.
• Mastering knowledge of applicable Quality FDA (Food & Drug Administration) Medical Device Directives/ Regulation and ISO (International Organization for Standardization) requirements through the updating of policies and procedures and acting as a liaison with appropriate policy experts
• Excellent writing and editing skills and computer skills travel within EU and International approximately 10-25%.

Required Knowledge and Experience:

• Relevant bachelors degree with a minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience
• Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA GMP QSR and ISO 13485 and MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry and knowledge of Medical Device Manufacturing processes/requirements
• Effective usage of data analysis tools analytical and research skills and problem-solving techniques with keen attention to detail and simultaneous understanding of the big picture and desire to follow an audit trail to identify risks non-conformances true root cause etc.
• Outstanding written oral communication and presentation skills in English and Dutch
• Sound judgement ability to make decisions work independently and ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and escalate issues.

2 or more years relevant experience in a Medical Device Manufacturing setting or equivalent like packaging and labeling and/or distribution and experience supporting and or participating in regulatory inspections and audits are considered advantages for this role.

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