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Principal Quality Assurance Engineer

I am working with a globally leading diagnostics company in Boston to secure a Principal Quality Assurance Engineer on an initial contract until the end of 2018 but is extremely likely to extend beyond this.

If you have 5+ years of Quality Assurance experience in the Medical Device industry (ideally some with reagents) and extensive experience with Design Controls, Design V&V, Process Validation, Risk Management and transfer of Design to Manufacturing, you are the kind of person we are looking for!

Key Responsibilities:

    • Practices, mentors and develops company concepts, policies and procedures
    • Implements strategic projects, acts as catalyst to remove organizational barriers, reduces cycle times and directs process improvements
    • Conceives, plans, and executes projects related to the strategic needs of the company
    • Provides cross-functional and departmental leadership in the area of quality engineering by providing technical advice and guidance as a consultant to other functional groups
    • Represents the Quality function as a member of project core teams, design reviews, and participates/leads cross-functional technical teams
    • Ensures that products meet design specifications and applicable product, process, and quality standards
    • Leads efforts to develop or improve processes directly or indirectly related to product development and contract manufacturing
    • Leads the investigations for product performance problems and component failures or non-conformances
    • Provides documentation review and approval to ensure regulatory compliance in the areas of configuration management and Design History Files for products undergoing development
    • Reviews and approves project specific documentation,
    • May participate in product and process risk assessments (including FMEAs, FTAs, etc.) and Risk Management File reviews

Key Skills & Experience Required:

    • 5-10 years of experience within the medical device industry
    • Knowledge and application of the requirements of the FDA QSR and ISO 13485
    • Extensive experience applying the principles of design controls, including specifications development/control, design verification/validation, process validation, Risk Management and transfer of design to manufacturing
    • Knowledge of and experience applying statistical techniques and tools

If this opportunity is of interest, apply now!

Sthree US is acting as an Employment Business in relation to this vacancy.