Quality Assurance Manager for Consumables (EW)
Posted: 19 Aug 2022
Are you ready for a new challenge? Are you a proactive Quality Assurance Manager? Then this role is for you!In this interesting role as a Quality Assurance Manager, you are working for a Pharma / Medical diagnostic company that offers solutions to health care, with a global presence. Tasks & Responsibilities:
- Support and enable the business partners regarding product care and product improvement activities as well as in all other quality aspects of the consumables products
- Ensure product quality and compliance with the regulatory requirements and the proper documentation of all activities
- Support our business partners by reviewing and approving projects-, products- and process documents, changes and deviations, Q&V activities, and releasing products
- Ensure improvements through CAPAs, SCARs, and process updates
- Lead and/or support special projects or initiatives in the area of quality and of our business partners
- Permanently optimize processes in order to increase quality and efficiency standards
Must Haves:
- Academic degree in an engineering or life science discipline or related work experience in Quality Management
- Min. 3+ years experience with the medical device regulations including ISO 13485 and FDA regulations for the above-mentioned processes
- Min. 3+ years experience in Quality Management, Quality Assurance, or Quality Control, preferred in the medical device industry at least in the regulated industry
- Technical and/or scientific understanding to be able to work with Business and Technical stakeholders
- Hands-on experience in leading a process improvement project
- Fluency in German and English, spoken and written (min. B2 Level in both languages)
- Strong communication skills
- od stakeholder management skills across all hierarchy levels
- Self-dependent, structured, quality-oriented, and determined
- Solution-oriented mindset, active and initiative personality
- A crucial contribution to the spirit of the existing team
Nice to Haves:
- SAP Skills
- Kledge of Injection Molding
We are looking forward to your application. od luck