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

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