Quality Engineer / Validation consultant

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.