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Senior CAPA Engineer

Andover, MA

Job Type: Contract
Job Id : 304868
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Position Summary

Our client is seeking a Senior CAPA Engineer to join their team.

What You'll Do:

  • Work across teams and across levels of management to make sure that CAPA action plans can be supported relative to resources available
  • Serve as a subject matter expert on TrackWise tool
  • Expected to periodically provide CAPA trending data to management for review
  • Responsible for CAPA investigations; from issue identification through solution implementation and monitoring
  • Serve as the project manager in all aspects of CAPA; cross functional resources, lead team meetings, provide deliverables according to the project timelines
  • Responsible for the maintenance of all CAPA records, easily ready for audit
  • Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques
  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances
  • Guide cross functional teams assigned to product CAPA:. to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product

Who You Are:

  • Bachelor's degree in engineering or scientific related field with 5 years of related experience in quality systems engineering 
  • At least 5 years of related experience in the medical device industry
  • Demonstrated ability to effectively interact with and influence employees, and managers on all levels
  • Must be goal-oriented and proactive in problem solving, coupled with creativity and a high energy level
  • Strong understanding of FDA regulations, international regulations
  • Strong written and verbal communication skills
  • Strong project management skills
  • Must be able to function with minimal supervision

Job ID: 264763

About Eliassen Group:

Eliassen Group has been driving the success of our clients, consultants, and employees within Technology Staffing and Consulting Services since 1989. For over 25 years, we have been at the forefront of innovation by uniting talented people and quality solutions within successful companies to help them attain their business objectives. Our solution oriented approach to understanding your needs ensures that we identify and represent the best possible talent available in the market, personally selected and matched to your requirements by our highly-tenured, extraordinarily capable recruiting team. Our consulting divisions include expertise focused on Agile, Biometrics & Data Solutions, Creative Services, Government Services, Life Sciences and Workforce Management. Eliassen Group is privately held and headquartered in Reading, MA.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

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