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Quality Systems Specialist
vor 4 Monaten
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver right way. That's the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.
A Day in the Life
The Quality Systems Specialist is working with highly motivated team members in a dynamic work environment. Great opportunity to interact with broad cross-functional groups within our manufacturing site or with sister manufacturing sites. Work is done with multiple departments: production, engineering, development, quality and business platforms.
The position is based in Tolochenaz, Vaud.
Responsibilities may include the following and other duties may be assigned:
- Is an expert for his/her Quality System(s) such as Change Control, CAPA, documentation, risk management, audit and/or training.
- Leads local and contributes to global continuous improvement initiatives to ensure his/her process performance and compliance
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Ensures process monitoring, reporting and improvement by providing leading KPIs.
- Trains stakeholders on his/her process.
- Participates for his/her Quality system audit and inspection preparation, resolution of audit and inspection findings.
- Collaborates with manufacturing, engineering and development functions to ensure quality standards are in place.
- Assures in his/her daily work an overall compliance to ISO 13485; 21 CFR Part 820 and EU MDR
- Bachelor's degree required
- Minimum of 2 years of relevant experience in medical device or pharmaceutical quality, within a production site
- Fluent in French and English
- Excellent communication skills
- A continuous improvement mindset
- Ability to work in a team environment as well as independently
- Exhibits high degree of initiative and good judgment.
- CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
