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Senior Quality Engineer


Requisition Number: P11737

Region: US
State: Massachusetts
City: Clinton

Responsibilities

Join the Phillips-Medisize team (formerly Injectronics) in this Senior Quality Engineering role to support manufacturing of medical devices for a variety of customers!

  • Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Coordinate new process techniques that improve overall job efficiencies
  • Implement systems and procedures that assure compliance with Quality Standards
  • Development and implementation of statistical incoming and in-process sampling/control plans
  • Manage the qualification of processes performed by PPC suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
  • Participate in AQP meetings representing quality, where appropriate
  • Provide engineering team with information and analysis tools as needed
  • Facilitate communication between engineering function, manufacturing, and quality
  • Responsible for being a communication liaison between the customer and manufacturing facility
  • Some programs may have vision requirements
  • Other duties as assigned

Qualifications - Education & Experience

  • Bachelor degree in an engineering discipline or equiv.
  • Minimum six (6) years quality/regulatory experience
  • Minimum Three (3) years auditing experience
  • Industry experience in medical device/drug delivery system highly preferred.

Qualifications - Skills & Competencies

  • Understanding of the project development process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from group of managers, sales, and customers
  • Strong communication (verbal and written), teamwork and organizational skills
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve customer satisfaction
  • Demonstrable track record of project accomplishment
  • Demonstrable track record of planning activities with contingency actions

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