Quality Systems Specialist

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

Careers that Change Lives

Ensure the quality of our life saving products is your mission. As Quality Systems Specialist, you are responsible for the quality of our products and compliance of our processes.

At the Swiss Medtronic Operations (SMO) site, we manufacture more than half of the defibrillators implanted worldwide. Our production site has a big impact on our patient’s lives.

As Quality Systems Specialist, 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.

Responsibilities

• Is the Subject Matter Expert for their Quality Systems such as Change Control, CAPA, documentation, audit and/or training.
• Leads local initiatives and contributes to global continuous improvement initiatives such as First Time Quality, Put Patient First or Quality Management System simplification.
• 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.
• Ensures process monitoring, reporting and improvement by providing leading KPIs for daily follow up and for Quality Management reviews.
• Presents and defends their process during notified bodies audits and regulatory authorities’ inspections. Leads for their 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.
• Trains stakeholders on their process.
• Assures in their daily work an overall compliance to ISO 13485, 21 CFR Part 820 and EU MDR.

Must Haves

• Engineering bachelor’s degree minimum
• Minimum of 4 years of relevant experience in medical device or pharmaceutical industry, within a manufacturing site
• 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:

• Annual Incentive Plan % depending on company results
• Pension scheme and group discount on healthcare insurance
• Employee Assistance Program and Recognize! (Our global recognition program)

The position is based in Tolochenaz, Vaud and is an on-site position (maximum one day work from home per week).

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 90,000+ 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.