Quality Systems Specialist.

Vor 7 Tagen

Tolochenaz, Schweiz Medtronic Vollzeit

Careers that Change Lives
Medtronic is hiring a Quality Systems Specialist responsible for the quality of our products and compliance of our processes at the Swiss Medtronic Operations (SMO) site, where we manufacture more than half of the defibrillators implanted worldwide, with eventually a big impact on our patient’s lives.

In the role, you will be working with highly motivated team members in a dynamic work environment. You will have great opportunities to interact with broad cross-functional groups within our manufacturing site or with sister manufacturing sites. You will act as a partner of the different departments: production, engineering, development, quality, and business platforms.

A Day in the Life
• Act as a Subject Matter Expert for Quality Systems such as Change Control, CAPA, documentation, audit and/or training.
• Lead local initiatives and contribute to global continuous improvement initiatives such as First Time Quality, Put Patient First or Quality Management System simplification. 
• Provide 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.
• Ensure process monitoring, reporting and improvement by providing leading KPIs for daily follow up and for Quality Management reviews.
• Present and defend their process during notified bodies audits and regulatory authorities’ inspections. Lead for their Quality system audit and inspection preparation, resolution of audit and inspection findings.
• Collaborate with manufacturing, engineering, and development functions to ensure quality standards are in place. 
• Train stakeholders on their process.
• Assure an overall compliance to ISO 13485, 21 CFR Part 820 and EU MDR in their daily work.

Must Haves
• Engineering bachelor’s degree minimum
• Minimum of 4 years of relevant experience in medical device or pharmaceutical industry, within a manufacturing site
• Experience in working in compliance to ISO 13485, 21 CFR Part 820 and EU MDR in their daily work
• Minimum 2 years of quality experience
• Change control experience
• Fluent in French and English
• Excellent communication skills
• Ability to work in a team environment as well as independently
• A continuous improvement mindset
• Exhibits high degree of initiative and good judgment.

Nice to Haves
• Root Cause investigations tools including DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts
• Project management

We Offer
We offer a competitive salary and benefits package to all our employees:
• Flexible working environment
• Annual Incentive Plan % depending on company results
• Pension scheme and group discount on healthcare insurance 
• Training possibilities via Cornerstone/Skills Lab
• Employee Assistance Program and Recognize (our global recognition program)

Our Commitment
Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world. 

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