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Sr. Quality Engineer (Medical Device)

  • Job type: Permanent
  • Location: Boston
  • Salary: $80000 - $110000 per annum
  • Job reference: MERZ
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 08/08/2017
SENIOR QUALITY ENGINEER
  • Multi-Million Medical Device Company
  • Boston, MA
  • $80,000 - $110,000 + Bonus + Benefits + Excellent Career Growth
A global medical device company is looking to hire a Senior Engineer of Quality Operations to join the team! This company is one of the world leaders committed to manufacturing, developing, and distributing high-quality technology and products for diabetes and oncology. This medical device company is family oriented, has a great work-life culture, and has been expanding in size! They offer a competitive base salary, bonus, benefits, and professional career growth!

The Senior Engineer of Quality Operations will be responsible for supporting and overlooking the quality operations of finished and in-process products, in addition to methods according to company standards.

The Senior Engineer of Quality Operations will perform the following responsibilities:
  • Implement preventative and corrective actions to prevent reoccurrences
  • Perform product failure investigations
  • Monitor and report nonconforming events for the follow areas: Clean Room, Receiving Inspection, Release and Final Packaging
  • Support CAPA, validation, development and implementation of Test Methods
  • Develop Quality Standards and Quality Instructions
  • Approve and review engineering changes in support of product life cycle
  • Respond to Internal Audits and provide Quality Assurance support
  • Establish QA assignments to subordinates
The Senior Engineer of Quality Operations will have the minimum requirements:
  • Knowledge of medical device design and process controls per ISO 13485 and FDA Quality System Requirements
  • Bachelor’s degree in Quality Engineering, Engineering, or Sciences
  • 5 - 8 + years experience in Manufacturing/Engineering or Quality Assurance environment
  • Previous design experience
  • Previous experience in handling nonconforming events
  • Strong communication, organizational and leadership skills
  • SAP and Packaging process experiences are a plus
  • Previous validation experience
  • Must be team oriented
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