Quality Systems Team lead
About the Role
Quality Systems Team Lead
Our client was established more than 30 years ago and is a global developer and manufacturer in the wound care and surgical market segments with a huge product portfolio. They have multiple sites across Europe and their products are sold in more than 70 countries. They value creativity and fresh ideas. That being said, if your next step is to grow into a leading position, you do not want to miss this opportunity!
- Maintenance and development of the quality management system in compliance with regulatory requirements
- Identification of improvement potentials for the QMS
- Operational and disciplinary management of a Quality Team
- Support and independently execute sub-projects for the management of the QMS
- Support Regulatory Affairs Team in product registration of medical devices, specifically in the context of MDR but also globally
- Participation in internal and external audits
- Support in responding to inquiries from Notified Bodies, local and international authorities
- Contribute to key QMS processes Non Conformity, CAPA, Change Control, etc.
- Support relevant stakeholders on conformance issues; including implementation of GxP in line with regulatory requirements and continuous improvement
- Provide training on quality topics
- Degree in Engineering, Science or related fields or equivalent
- Relevant professional experience in Quality Management, Regulatory Affairs, Medical Devices, Pharmaceutical or GxP
- Thorough knowledge of QMS regulations and ISO quality requirements (e.g. ISO 13485)
- Highly driven, capable of acting on one's own initiative, with excellent analytical skills and an agile mentality
- Strong communication, adaptability and leadership skills
- Fluency in English and German
Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+49 30 1663 7750