Perform supplier audits in accordance with global audit schedule, including planning, performing audits, documenting reports and managing follow-up actions
Perform internal audits in accordance with global audit schedule
Manage CAPA process, leading investigations, root cause analysis, implementing corrective and preventive actions and documenting related activities
Manage local quality system procedures, ensuring alignment of processes between legal manufacturer and authorized manufacturing site
Lead preparations and participate in external audits to ensure a successful outcome
Manage quality training process to ensure compliance with documented training plans, assisting with training assignments, recording and reporting
Maintain competence in regulatory requirements and industry trends for medical device quality systems (principally ISO 13485, 21 CFR 820)
Participate in quality assurance improvement projects
Bachelor or Master degree in Engineering or relevant area
Minimum of 5 years relevant working experience, including experience in ISO 13485 environment, and preferably with implantable medical devices
In-depth knowledge of ISO 13485 quality systems, experience with GMP inspections and strong auditing experience
Willingness to take on projects as necessary to assist/lead continuous process improvements for the QA function, locally and globally
Demonstrated leadership experience and very good communication and presentation skills
Team oriented person with good organizational skills and ability to work under pressure
Fluent in English, ability to write and speak German is a definite advantage
We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.
Jennifer Hofmann, Human Resources Manager, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.
For this vacancy only direct applications will be considered.