Quality Systems Specialist
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Job Location:
Lausanne - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ 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
Ensure the quality of our life saving products is your mission. As Quality Systems Specialist you are responsible of 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 patients 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 may include the following and other duties may be assigned:
- Is the Subject Matter Expert for their Quality Systems such as Change Control documentation and training.
- Leads local improvement initiatives acts as a game changer for his/her quality system.
- Develops his/her network showcases his/her achievements outside the site and brings best practices from others to the site.
- 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 ISOCFR Part 820 and EU MDR
Required knowledge and experience
- Minimum of 4 years of relevant experience in medical device or pharmaceutical industry within a manufacturing site with a minimum of 2 years of quality experience
- Engineering background Engineering bachelors degree minimum
- 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.
#LI-Onsite
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:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
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
