Design Quality Engineer
CK QLS are recruiting for a Design Quality Engineer to join a company in the Medical Device industry at their site based in Oberdorf on a contract basis until the end of 2020.
Design Quality Engineer Role: The main purpose of the role will be to:- Play a key role in the team, focusing on the Life Cycle Management activities.
- Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
- Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
- Conduct and lead design verification and validation activities.
- Conduct and lead design / process failure mode effects and analysis.
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
Further responsibilities will include:
- Effective communication at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Sharing knowledge and following all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Accountability for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A minimum of a Bachelor's degree in Engineering or related Technical or Scientific discipline with hands on experience in related field is required.
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
- Experience in a Medical Device regulated environment.
- Previous Quality Engineering experience is preferred.
- Development and manufacturing experience is preferred.
- Fluency in English is required, good knowledge of German would be a strong asset.
The Benefits: This is an excellent opportunity to join a global medical device company.
Apply: For more information or to apply for this Design Quality Engineer position, please contact Adrien Guimard on 0041 (0) 782508535 or email email@example.com, quoting job ref 48311.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in the country where the services will be delivered.