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!
- 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.