Beschreibung
You are an outstanding Quality Engineer with experience in the pharmaceutical area especially in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client one of the biggest pharmaceutical companies worldwide needs you for a 6 months TRD project. The Technical Requirement Document (TRD) is a CFDA submission. Within this project our client needs to review its Design Requirements against the current China GB/YY standards and the submitted TRD documentation and update the TRD as needed.
Your duties and responsibilities:
- Within the Design Quality team you're focusing on life cycle management activities
- You're enhancing the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement
- You're applying statistical methods and processing/designing excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies
- You' re providing leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc
- You're providing leadership in the understanding of medical device regulations to other disciplines
- You know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
What we require:
- A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required
- Proven exceptional written and oral presentation skills
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required
- Previous Quality Engineering experience is preferred
- Experience in a Medical Device regulated environment
- Fluency in English is required, good knowledge of German would be a strong asset
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.