design quality engineer in Oberdorf

posted
contact
Olivier Worch, Basel Professionals Health Care & Life Sciences
job type
temporary
apply now

job details

posted
location
oberdorf, nidwalden
sector
Life Sciences
job type
temporary
reference number
12067
contact
olivier worch, basel professionals health care & life sciences
phone
058 201 55 50
apply now

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

 

PROJECT DESCRIPTION:

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  olivier.worch@randstad.ch  or call me at 0041 58 201 55 55

I am looking forward to hearing back from you