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Principle Quality Assurance Engineer - Boston, MA
Ref No.: 18-12684
Location: Indianapolis, Indiana
Principle Quality Assurance Engineer  
Boston, MA
03+ Months Contract 

  • 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.
  • Develops and maintains broad external and internal contacts as required to accomplish job objectives.
  • 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
  • Utilizes advanced knowledge and experience within a specific field/area (e.g. IVD instruments, reagents, software, etc) to provide technical analysis of related information/data (REAGENT EXPERIENCE PREFERABLE)
  • Leads efforts to develop or improve processes directly or indirectly related to product development and contract manufacturing, which are intended to support regulatory compliance or process efficiency
  • Identifies opportunities for improvement, and provides feedback to management
  • Leads the investigations for product performance problems and component failures or nonconformances identified through customer complaints or internal testing/inspection with intent to identify the root cause and develop and implement corrective action
  • 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, including but not limited to verification protocol and reports, plans, requirements, etc.
    May participate in product and process risk assessments (including FMEAs, FTAs, etc.) and Risk Management File reviews
Requirements :

  • 5 – 10 years of experience within the medical device industry.
  • Requires strong knowledge and application of the requirements of the FDA's Quality System Regulation (QSR), ISO 13485, clear understanding of 820 requirements.
  • Extensive experience applying the principles of design controls, including specifications development/control, design verification/validation, process validation, and transfer of design to manufacturing.
  • Experience applying the principles of risk management.
  • Knowledge of and experience applying statistical techniques and tools.
  • Strong problem solving, decision making, project management, and leadership skills.
  • Excellent writing, communication, and organizational skills.
  • Excellent interpersonal and team-oriented skills.