design quality engineer in Oberdorf

Olivier Worch, Basel Professionals Health Care & Life Sciences
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job details

oberdorf, nidwalden
Life Sciences
job type
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olivier worch, basel professionals health care & life sciences
058 201 55 50
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job description

Randstad Professionals is currently looking for a Design Quality Engineer  who will be assigned an interesting challenge for a major client (medical device)  based in Oberdorf (Switzerland) .

This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector  (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start January 2019 and will last until December 2019



By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR) 2017/746.  This long term contract will be assigned in the framework of the implementation of these guidelines.

Tasks / Responsibilities:

  • Design Quality team member focused on life cycle management activities.

  • Enhance the Design Control and Risk Management processes 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 CAPA, Complaints, Nonconforming Materials, Risk Management, etc.

  • Provide leadership in the understanding of medical device regulations to other disciplines.

  • Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.

  • Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.

  • Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.

Education / Experience.

  • 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 an Medical Device regulated environment

Other requirements:

  • Excellent problem solving, decision-making, and root cause analysis skills are required.

  • Interpersonal skills that foster conflict resolution are required.

  • Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.

  • Ability to multi-task independently with minimal supervision

  • Working knowledge of material science and mechanical product knowledge is preferred.

  • Development and manufacturing experience is preferred.

  • Fluency in English mandatory, good knowledge of German would be a strong asset.

If you are interested to get extra information about this role, don’t hesitate to get in touch with me.

You  can reach me either at  or call me at 0041 58 201 55 55

I am looking forward to hearing back from you