Design Quality Engineer

  • Salary: 90-105 CH per hour
  • REF Number: 00048311
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 782508535
  • Date Published: 03.06.2020
  • Sector: Medical Devices
  • Location: Central Switzerland
  • Discipline: Technical - Validation, Technical - Production/Manufacturing

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, 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.

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