Chief Executive Officer
Limiting Uncertainty For The Busiest Surgeons
Senior Quality EngineerBoston, MA (On-Site)
The Sr. Quality Engineer will be responsible to serve as Subject Matter Expert in the areas of Quality Engineering, Risk Management (pFMEA), Process/Test Method/Equipment Validations,deviations, and NC and CAPA investigations. This role will be responsible for independently leading and documenting these activities to support production and manufacturing. This role will be responsible for mentoring junior Quality Engineers.
Primary responsibilities include:
•Lead CAPA investigations and action plan / VoE completion
•Lead Nonconforming product investigations
•Lead pFMEA and support all risk management activities
•Supporting equipment management activities
•Supporting process, test method and equipment validations
•Supporting changes to design or manufacturing
•Collection and reporting of metrics and data as required
•Leading and supporting site improvement initiatives
•Bachelor’s Degree is required, preferably in Quality Assurance, Engineering or Biological Sciences.•Minimum 5 years experience in Quality Engineering in Medical Device or similar FDA regulated industry.•Demonstrated experience in successfully leading a team.•Experience with measurement systems and statistical techniques.•Working knowledge of QA Engineering related QMS elements including DesignControls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and PackagingControls, Handling, Storage, Packaging and Distribution of Product.
•Experience with CAPA processes including investigational techniques.•Experience with Risk Management regulations and application (ISO14971).•Working knowledge of medical device regulations (including FDA QSRs,ISO13485).•Strong technical aptitude (i.e. able to read and comprehend technicaldocumentation, ability to comprehend and execute procedures, demonstratedunderstanding of system documentation).•Ability to work independently with minimal supervision.•Ability to communicate effectively (both written and oral) at different levels of the organization.•Experience with development and implementation of quality system procedures.•Certified Quality Manager or Certified Quality Engineer desired but not required.