Senior Quality Engineer

Woburn, Massachusetts | Quality Assurance / Safety

Sr. Quality Engineer

Our client is a med device start-up looking for exceptional Quality talent. We have worked with them for several years in various situations and they have been successful with every product they’ve developed. The more broad-based your experience is in Quality the better, as you will be involved across the breadth of the QS; defining, implementing and maintaining the system. The challenge will include writing, editing, and executing test protocols and SOP’s.

From the DHF to Risk Assessments to the documentation for Preclinical and Clinical Testing this will be a significant learning opportunity for the right candidate. The product category is the structural heart so any experience you bring in that anatomy will be a big plus but it’s your QS skills we will be laser focused on. This position will be concentrated on R&D efforts in its early stages and transition into some manufacturing demands over time.

Responsibilities:

  • Hands-On SME for all day-to-day Quality activities
  • Authors reports for and maintains the DHF, i.e. capturing product rationale and ECN reasoning
  • May perform any documentation function relative to the QS, e.g. Creating/Updating/Organizing/ Maintaining SOP’s, writing Test Protocols and other QS documentation
  • Coordinates Quality efforts around preclinical testing including animal, bench, and biocompatibility testing
  • Interacts with R&D to warrant the complete, timely, and organized capture of Design Control documents
  • Supports R&D design efforts, executing testing and writing appropriate reports on results
  • Works with suppliers; auditing capabilities & systems, ensuring traceability as needed, and establishing the inspection needs for incoming product
  • Will be involved with Design Review, Risk Management, and Root-Cause/CAPA
  • Maintains the files on engineering studies, Regulatory related to filings, V&V, and training
  • Is a participant in preclinical/clinical cases to ensure the safety and performance of the devices
  • May be involved with IQ/OQ/PQ type efforts as they relate to new equipment

Requirements:

  1. BS in Engineering, Science or equivalent technical discipline
  2. 5 years’ experience in a Quality position in the Medical Device space
  3. Demonstrable skills in ISO 13485 & 21 CFR 820; ISO 14971 highly desired
  4. Capable of independent work as an individual contributor or on a team
  5. Experience with the Class III FDA designation is preferred
  6. Travel up to 40%
  7. Experience with CAD (SolidWorks or Inventor) desired
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