Quality Engineer medical devices

Switzerland  ‐ Vor Ort
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Beschreibung

Our client has a need for a quality engineer to support new product introduction activities related to risk management and technology transfer

Responsibilities:
  • 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.
Start
11/2019
Dauer
12 months
Von
Michael Bailey Associates
Eingestellt
09.10.2019
Projekt-ID:
1833087
Vertragsart
Freiberuflich
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