Quality Engineer

Bedford, Massachusetts, United States | Full-time

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As a Quality Engineer at Affera, you will be responsible for various programs within our Quality Management System and for driving day-to-day compliance in the development and manufacturing of leading edge medical devices.

 We are looking for bright, hands-on individuals who are interested in making a difference in a dynamic and exciting entrepreneurial environment.

Responsibilities

  • Review and approve Quality Records, such as product inspections, LHRs, NCMRs, CAPAs, and RMAs.
  • Manage several key QMS Programs such as Receiving, Inspection, Non-Conforming Materials, CAPA, and Lot Release.
  • Create and distribute QMS reports on a routine basis to communicate the status of various QMS processes.
  • Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
  • Support Supplier Qualification by conducting performance assessments, and managing the Approved Supplier List.
  • Conduct and lead all MRB and CAPA meetings.
  • Support the maintenance of a robust Environmental Monitoring program for the company’s controlled environment room areas.
  • Support the maintenance and reporting of routine product bioburden and endotoxin monitoring for all applicable products.
  • Support quality system development, implementation, and execution to US and international standards, including compliance to ISO13485:2016, EU 2017/745 (MDR) and US FDA 21 CFR requirements.
  • Support the Internal and External QMS Audit program, ensuring audit compliance and adequate follow-up to audit nonconformances.
  • Support risk management programs to ensure compliance with ISO 14971 and partner with engineering to drive design control processes.
  • All other tasks as assigned.

 

Qualifications and Experience

The ideal candidate will be a motivated individual looking to grow professionally in a fast-paced environment. Strong analytical skills, excellent knowledge of theoretical and practical fundamentals, and a solid ability to work on multiple projects simultaneously are required.

  •  BS in Engineering (Biomedical, Industrial, Mechanical, Operations, or Quality) from a top tier institution preferred.
  • 3+ years of work experience in medical device industry. Start-up or small company experience strongly preferred.
  • Demonstrated success working within quality management systems.
  • Working knowledge of US and international medical device regulations.
  • Prior experience with the US FDA IDE clinical investigations and EU Clinical Evaluations in support of CE mark is preferred.
  • Training in EU MDR or prior experience in supporting MDR transition projects is preferred.
  • Flexibility and willingness to adapt, strong team orientation and ability to lead in a cross-functional environment are a must.
  • CQE or equivalent certifications are preferred.

Perks

  • Contribute to an innovative solution that can improve the lives of millions.
  • Work alongside highly talented engineers and prominent leaders in the industry.
  • Bright, motivated co-workers in a fun and collaborative office environment.
  • Competitive salary, PTO, medical coverage, 401k.