QA Manager Combination Product and Device (m/f/d)
Responsibilities
- For allocated Medical Device / Combination Product development projects:
- Serve as the Quality SPOC for allocated Device Development or commercial project and ensure all projects follow the applicable design control and risk management procedures
- Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product
- Create and deploy Risk Management Plan / Report, actively participate up to facilitating FMEAs, define Delivery System specifications accordingly including Drug Product / Component interface, and ensure all necessary release GMP documentation are completed and in place
- Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls
- Represent department at Quality Review Board and Change Review Board meetings
Profile
- BS degree in Life Sciences discipline or Chemical/mechanical engineering, Graduate degree preferred
- Experience and hands on expertise in device quality or device development
- Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
- Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred
- Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)
- Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
- Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
- Fluent in English, German advantageous
Benefits
- Unlimited employment contract with Hays (no Freelancing)
- A very renowned company
- Fascinating, innovative environment in an international atmosphere
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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