EMEA Sterility Assurance Leader.

Medtronic; Lausanne; Vor Ort; CHF 110’000 - 150’000; Vollzeit

Zusammenfassung

Medtronic seeks an EMEA Sterility Assurance Leader to lead the sterility assurance team across 8 manufacturing sites in Europe. This role involves maintaining high-quality standards, ensuring regulatory compliance and managing personnel effectively. Ideal candidates will have significant experience in medical devices, strong leadership skills, and a pragmatic approach.

Leistungen

Competitive salary

Flexible benefits package

Qualifikationen

• Minimum 7 years of relevant experience in the medical device or pharmaceutical industry.
• At least 5 years of experience in people management.
• Fluency in English.

Aufgaben

• Oversee quality programs ensuring compliance with policies.
• Collaborate with sites for inspection preparations and audits.
• Drive performance of EMEA Sterility Assurance organization.

Kenntnisse

Team spirit

Pragmatic approach

Business-oriented mindset

Ausbildung

Bachelor's degree in Microbiology or related field

Jobbeschreibung

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 Medtronic is hiring its EMEA Sterility Assurance Leader responsible for leading the sterility Assurance EMEA team and representing the EMEA Region in Medtronic Global Sterility Assurance organization.

In the role, you will be reporting to the EMEA Quality Operations Lead and will be part of the EMEA Quality Operations LT. Your scope will cover 8 manufacturing sites located in 5 different countries (The Netherlands, Germany, France, Israel and Switzerland).

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

• 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.
• Collaborate with sites in inspection preparation, resolution of audit and inspection findings, organize the coordination of activities with external suppliers, mainly Sterilization providers, to ensure timely delivery of products, while also overseeing the investigation and evaluation in case of issues occurring in our different sites, and selecting, developing and evaluating personnel to ensure the efficient operation of the function.
• Drive the performance of the EMEA Sterility Assurance organization, provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance, work directly with sites and operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external, ensure the Sterility Assurance programs and policies are maintained and modified regularly.
• Facilitate uniform standards at regional level and enables best practice sharing, thereby fostering the achievement of company's mission globally
• Guide the conceptualization of new methodologies, materials, machines, processes or products.

Required knowledge and experience

• Bachelor’s degree, ideally in Microbiology or a related field and minimum 7 years of relevant experience in the medical device or pharmaceutical industry.
• At least 5 years of experience in people management.
• Fluency in English
• Availability to travel up to 20 % of working time.
• Team spirit, experience in collaborating with stakeholders at different levels
• Pragmatic and hands-on approach
• Growth and business-oriented mindset.

#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 95,000+ 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