Quality Systems Manager Mdr

Vor 6 Tagen

Zug, Schweiz SHL Group Vollzeit

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

**Job Overview**

The position of Quality Systems Manager MDR is responsible for the QMS compliance to all applicable regulations including MDR and cGMP. It is part of the leading quality assurance function for the MDR Quality Management System. Actively provides guidance to multiple departments and sites regarding compliance to the applicable SHL Quality and Regulatory procedures including applicable Agency policies and regulations. Job holder is directly involved in the establishment of local procedures. Job holder is Project Manager for the establishment of the MDR Quality Management system and the implementation of the procedures at the site.

**Main Responsibilities**
- Build and maintain certified MDR Quality Management System
- Lead product registration process with Notified Body
- Represent the QMS as deputy PRRC
- Maintain local training compliance
- Lead and participate in internal audits
- Provide Quality related trainings
- Organize site Management Review
- Track and report KPIs
- Supplier qualification including leading of audits
- Site QARA projects

**Skills and Qualification**
- Bachelor’s degree in Life Science or equivalent
- Minimum of 5 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
- Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing organization under MDR regulation
- Expertise in MDR, cGMP and other Regulatory compliance requirements
- Experience in software development in the medical device context
- Self-confidence and the ability to work with all levels of organization
- Operates in a way that never compromises ethics and integrity
- Advanced leadership skills
- Ability to understand and adapt to different cultures and market needs
- (Inter-)national travel as required by business (up to 10%)

**We Offer**
- An exciting opportunity in a fast-growing international medical device company
- A modern working environment, with multicultural and dynamic teams
- Flexible working hours and a hybrid remote work policy
- A centrally located office in Zug, very close to the train station

  • Director Emea Quality Systems

    vor 1 Woche

    Zug, Schweiz Johnson & Johnson Vollzeit

    Ethicon is recruiting for a Director, EMEA Quality Systems, located in Zug, Switzerland. Lead the Ethicon Quality Systems processes and organization by: - Ensuring the Ethicon processes in EMEA are effectively maintained achieving a state of compliance across all Ethicon sites. - Providing management with timely and comprehensive quality data that supports...

  • Vice President, Quality International

    vor 2 Wochen

    Zug, Schweiz Hologic Vollzeit

    **As a leading innovator of womens' health, we at Hologic are empowering people to live healthier lives everywhere, every day,** Our quality teams are at the heart of Hologic’s mission, driving innovation and ensuring reliable solutions. They lead the development and implementation of a global vision for quality to influence strategic and operational...

  • Manager, Quality Compliance

    Vor 6 Tagen

    Zug, Schweiz Seagen Vollzeit

    Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to...

  • Manager, External Quality Operations

    vor 2 Wochen

    Zug, Schweiz Seagen Vollzeit

    Position Summary: Principal Responsibilities: - Serve as Quality Single Point of Contact on one or more internal Virtual Management Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives - Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with...

  • Quality Assurance Associate

    vor 2 Wochen

    Zug, Schweiz Panda International Vollzeit

    QA Associate This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on...

  • Quality Manager

    vor 1 Woche

    Zug, Schweiz Siemens Vollzeit

    **We make real what matters**. Siemens Smart Infrastructure intelligently connects energy systems, buildings, and industries. We help our customers to thrive, communities to progress and support sustainable development to protect our planet for future generations. Join our team of about 320,000 colleagues around the globe and help us create environments...

  • Manager, External Quality Operations

    Vor 6 Tagen

    Zug, Schweiz Seagen Vollzeit

    Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to...

  • Quality Assurance Manager

    vor 2 Wochen

    Zug, Schweiz Viatris Vollzeit

    7087 Mylan Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Senior Quality Assurance Manager

    vor 2 Wochen

    Zug, Zug, Schweiz Viatris Vollzeit

    Viatris Pharma GmbHAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of...

  • Manager, Global Procurement Drug Delivery Systems

    vor 2 Wochen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is recruiting for a Manager, Global Procurement Drug Delivery Systems (DDS) for their pharmaceutical division. This position has a primary location of Titusville (NJ) but consideration will be given to the Raritan (NJ), Beerse (BE) or Zug (CH) locations as well. Caring for the world, one person at a time has inspired and united the people...