Quality Engineer

Remote, USA

Posted: 04/11/21 Category: IT Quality Assurance Job Number: 10892

Job Description


Position: Quality Engineer
Location: Remote (team in Boston, MA)
Job Type: Contract
Duration: 9 months to start

Job Description

Position Summary:
  • The incumbent applies systems engineering and quality assurance principles and techniques to the product development lifecycles.
  • The position will focus heavily on complaint investigation and processing activities.

Responsibilities:
  • Investigate and process medical device complaints and maintain open complaint level to acceptable levels.
  • Assist in maintaining quality system information databases as assigned.
  • Evaluate quality data and prepare periodic reports to monitor trends.
  • Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
  • Process non-conforming material reports including MRB dispositioning.
  • Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
  • Other Quality Engineering tasks as assigned

Education & Qualifications:
  • B.S. in Engineering or related field
  • 0+ years related quality assurance, software quality engineering experience or an equivalent combination of experience and education.
  • Medical device experience preferred.
  • ASQ certification a plus.
  • Beginning knowledge of FDA Quality System Regulation 21 CFR Part 820.
  • Good organizational, attention to detail and follow-through skills.
  • Excellent verbal communication and customer interface skills.
  • Ability to interface with multiple groups in the organization.
  • Basic computer skills – word processing, spreadsheet, windows.
  • MS Office preferred.

Job Requirements

TBD

Meet Your Recruiter

Chelsea Calvanese

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