Quality Engineer medical devices

This job has now expired please search on the home page to find live IT Jobs.

Our client has a need for a quality engineer to support new product introduction activities related to risk management and technology transferResponsibilities:implementing and reviewing risk management tools and methodology

* contributing to Design Control system and transfer the product to manufacturing stage

* Support and lead design control activities for NPI projects

* manage supplier risk management activities

* Establish and review NPI 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 to support NPI project teams

* 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.Requirements:A minimum BS degree in an engineering or technical discipline is preferred with 5 years of related experience in required.

* Fluent in English and French languages

* Knowledge and application of FDA QSR, ISO 13485:2003, and ISO 14971:2007

* Strong quality engineering skills with a proven track record in design verification/validation process verification/validation, and design/process failure modes and effects analyses is strongly preferred

Michael Bailey International is acting as an Employment Business in relation to this vacancy.