Senior Quality Manager
A global medical technology firm that is providing clinically proven solutions to improve the quality of life for patients are expanding their Quality department. As the Senior Quality Manager, you will be a part of a global team. You will have leadership of the Quality department - including Quality Assurance Engineers, supervise Quality Control and Quality Management Representatives.
The role:
- Responsible for management of the Quality function and QE supporting commercial manufacturing
- Responsible for the implementation, development and improvement of an effective quality management system
- Manage all internal/ external FDA, EU MDD/MDR and ISO 13485 audits and support supplier audits
- Experienced in interpreting the regulatory requirements for medical devices in the EU and/or USA
- Experience driving significant process improvement efforts, leveraging Lean 6-Sigma concepts and methodologies.
- Responsible for delivering to Quality budget
- Provide management support with regards to hiring, training and developing the Quality Team
Requirements:
- Bachelor's degree in engineering or related Field
- 8 years' experience within the Medical Device Industry within Quality and 3 years' experience in a management position
- Expert knowledge of Quality System Standards ISO 13485, MDD/EUMDR
- Fluent in German and English
Are you interested? Apply now and discover more about this role.