You manage quality programs to ensure compliance with standards while collaborating with various sites and suppliers. Your role involves overseeing performance and guiding the development of new methodologies within the Sterility Assurance domain.
Anforderungen
- •Bachelor’s degree, ideally in Microbiology
- •Minimum 7 years relevant experience
- •At least 5 years of people management
- •Fluency in English
- •Availability to travel up to 20%
- •Team spirit and stakeholder collaboration
- •Pragmatic and hands-on approach
- •Growth and business-oriented mindset
Deine Aufgaben
- •Oversee development of quality programs and procedures.
- •Ensure compliance with internal and external standards.
- •Collaborate on inspection preparation and audit resolution.
- •Coordinate activities with external suppliers for timely delivery.
- •Investigate and evaluate issues across different sites.
- •Select, develop, and evaluate personnel for operations.
- •Drive performance of the EMEA Sterility Assurance organization.
- •Provide guidance on policies and regulatory compliance.
- •Perform ongoing process analyses and enforce requirements.
- •Prepare reports and necessary documentation for stakeholders.
- •Maintain and update Sterility Assurance programs and policies.
- •Facilitate uniform standards and best practice sharing.
- •Guide conceptualization of new methodologies and processes.
Deine Vorteile
Competitive salary
Flexible benefits package
Wide range of resources
Support at every career stage
Original Beschreibung
# EMEA Sterility Assurance Leader.
**Lausanne, Vaud, Switzerland** | **Full time** | **Hybrid**
# 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.