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Senior Quality Engineer

2019-02-28 CLS Services | Leiden | HBO | Fulltime | Sluit 2019-04-29

Are you looking for a temporary job in Quality Engineering? Do you have experience with statistics and risk documentation? This can be the right job for you! In your job as Senior Quality Engineer you optimize systems and processes that are aligned with Mentor’s strategy and mission effecting ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Mentor Medical Systems, we are searching for a Senior Quality Engineer.

Company profile
A Global Leader in Aesthetic Medicine Founded in 1969, Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic medicine market. The Company develops, manufactures, and markets innovative, science-based products for aesthetics markets around the world. Headquartered in Santa Barbara, California, Mentor has manufacturing and research operations in the United States, Mauritius, and the Netherlands. Mentor has made breast implant devices for more than 20 years. Mentor#39;s breast implants are for use in both breast augmentation and breast reconstruction and are of the highest quality, and made under strict standards of design and testing.



Job description
Are you looking for a temporary job in Quality Engineering? Do you have experience with statistics and risk documentation? This can be the right job for you!
In your job as Senior Quality Engineer you optimize systems and processes that are aligned with Mentor’s strategy and mission effecting continuous quality improvement.
Responsibilities and key tasks:

  • Support, consult, train, and lead quality improvement projects throughout the life cycle of Mentor products. This includes product design and development, manufacturing, purchasing and improvements;
  • Utilize statistical tools and techniques to establish sampling plans. Support engineering activities in process and vendor specification development;
  • Analyze process-, product-, test- and Quality Management System data and investigate for improvement opportunities;
  • Responsible for pFMEA documentation and leading pFMEA meetings;
  • Review validation documentation (eg. IQ, OQ, PQ and verification studies);
  • Lead or is team member of CAPA investigation and Internal audit observation investigation;
  • Investigate instances of nonconforming material and support the determination of cause, corrective action and recommendation of the disposition of product;
  • Ensure that software validations are performed according to applicable FDA guidelines. Provide end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.


Who we're looking for
The ideal candidate has a BSc. background in engineering, science, mathematics or statistics and at least 3 years of related manufacturing experience. You have experience with quality improvements, statistics, risk documentation and you are able to communicate effectively within diverse interdepartmental groups. Preferably, you have a Six Sigma Blackbelt or Greenbelt certification.
Are you the experienced Quality Engineer we are looking for?

Additional vacancy information
Reference: A1900029
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
Terms: Fixed term assignment (9 months project).Full time strongly preferred, 32 hours discussable for strong profile fit.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555



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