(Senior) Quality Manager
Our client Is an international manufacturer of medical devices for Class IIb - III in the implantable field.
Their Karlsruhe office is home to 100 employees who all work towards innovative products, continued development and collaborative problem solving for the medical industry.
To strengthen their team in RA/QM, they are searching for a (Senior) Quality Manager to be responsible for continued compliance to ISO 13485, internal/external auditing and close working with the RA department on MDR changes.
- Contact for customers and suppliers in all quality-related questions
- Ensuring compliance with ISO 13485: 2016, FDA CFR 21 Part 820 and other national and international requirements as well as the specified customer requirements
- Processing customer complaints in close cooperation with various departments
- Planning and implementation of internal and external audits, including tracking any deviations found
- Monitoring of suppliers for compliance with the contractually agreed quality requirements
- Planning and carrying out supplier audits and tracking the deviations found
- Monitoring corrective and preventive measures
- Support for all areas of the company in the creation, implementation and maintenance of processes and corresponding quality-relevant documents (especially in the area of ??quality assurance)
- Completed business or technical vocational training or preferably a degree in engineering, medical technology or the like
- Completed further training in quality management and regulatory affairs is a prerequisite
- Several years of professional experience in the field of quality management systems and quality assurance in an international environment, ideally with medical devices
- In-depth knowledge of the applicable national and international regulatory requirements, including ISO 13485: 2016, MDD 93/42 / EEC, MDR 745/2017 and FDA 21 CFR 820
- First leadership experience is preferred
- Experience in project management and process validation
- Very good knowledge in dealing with MS Office software
- Very good knowledge of English and German
- Positive attitude, entrepreneurial mindset and result-oriented work approach
- Resilient, reliable and ready to learn new things
- Strong organizational and communication skills as well as the ability to work in a team
- Attractive company pension plan
- Capital accumulation benefits
- Training opportunities
- and much more
Please apply with your CV or contact the job poster Rebecca Stevens for further details.
+44 208 638 5376