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Quality Engineer / Validation consultant

  • Salary: CHF65 - CHF72 per hour
  • Job type: Contract, Full-time
  • Location: Neuchâtel
  • Sector: Other, Pharma & Life Sciences
  • Date posted: 21/06/2018
  • Job reference: J388473AJMK-210618

Senior Quality Engineer / Validation Consultant


Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.

For one of our client, specialized in the medical devices area based Neuchatel, we are looking for a Senior Quality Engineer and Validation Consultant.

This is a challenging, contracting position, starting in July until the end of 2019.

Responsibilities:

  • Support and lead design control activities
  • Champion supplier risk management activities
  • Establish and review protocols, reports, procedures, specifications and systems to provide QSR / ISO compliance consistent with the development of medical device products
  • Conduct and lead process validation activities
  • Conduct and lead process/design failure mode effects and analysis
  • Develop inspection methodology and acceptance criteria for inspection sample plans
  • Apply statistical methods to evaluate test data and processes.
  • Perform test method validation and Gage R&R studies for new inspection techniques and test equipment
  • Conduct internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements
  • Perform product / process specific supplier assessments
  • Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc.
  • Provides leadership in the understanding of medical device regulations to other disciplines.
  • Support Base Business and Production Improvement Initiatives

You bring to this role:

  • BS degree in an engineering or technical discipline
  • Knowledge and application of FDA QSR, ISO 13485:2003, and ISO 14971:2007 is
  • Strong quality engineering skills with a proven track record in design verification/validation process verification/validation, and design/process failure modes and effects analyses
  • Experience with Blueprint literacy including GD&T
  • Previous experience in a medical device or a healthcare company
  • Proven track record experience in implementing Quality System improvements to meet compliance and overall business goals
  • Proficiency with the Microsoft Office Suite is preferred
  • Knowledge of MiniTab is a plus
  • Strong communication skills with fluently in English and French

Start Date: 02.07.2018

Location: Neuchatel

If you've any further questions on the role please call Julie Mackerer on +41 61 282 22 17.


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