Quality Engineer in Billerica, MA at Volt

Date Posted: 11/21/2020

Job Snapshot

Job Description

Quality Engineer

Direct Hire Opportunity!  We are seeking a Quality Engineer to join our client, an ISO 13485 registered company that has been manufacturing machined and finished assembly products for the medical industry for over 30 years. 

Summary of Position

The candidate will support new product development as well as sustaining product.  The ideal candidate will have experience in an ISO and FDA QSR regulated environment.  Responsibilities include:

  • Perform validations (IQ/OQ/PQ) on equipment and processes
  • ECO generation and implementation on Procedures and WI
  • CAPA generation and implementation
  • Assist with MRB dispositions
  • Work with engineering regarding customer risk management activities (PPAP programs, PFMEA’s, Control Plans, etc.)
  • Identify process problems and implement corrective actions
  • Calibration maintenance

Qualifications:

  • Bachelor of Science in Engineering required
  • Minimum 5 years of medical device experience required.
  • Lean manufacturing and Kaizen skills are a plus
  • Regulatory experience a plus
  • CMM experience a plus         

Volt is an equal opportunity employer.