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.