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Job Details

Sr. Quality Engineer (Medical Device)

Company: EPM Scientific
Location: Boston
Reference: MERZ
Closing Date: 22 Aug 17
Type: Permanent
Salary (£): 100,000+

Job Summary:

SENIOR QUALITY ENGINEERMulti-Million Medical Device CompanyBoston, MA$80,000 - $110,000 + Bonus + Benefits + Excellent Career GrowthA global medical device company is looking to hire...



  • 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

Apply for this job: Sr. Quality Engineer (Medical Device)

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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