Quality Engineer

Location: 4 Gill Street, Unit B, Woburn, MA 01801

Reports to: Lead Quality Manager

Employment Type: Full-Time, In-Office

Compensation: $100,000-$110,000

Stem Wave is a fast-growing medical device company based in Massachusetts, pioneering orthopedic shockwave technology in the U.S. Our technology is helping change the lives of practitioners and patients by advancing healing and expanding access to effective, non‑invasive pain management solutions. Recognized among the fastest-growing privately held companies in 2023 and 2024, we are continuing to expand our team and capabilities to support rapid growth.

We operate at the crossroads of medical device and technology, combining the rigor of a regulated healthcare environment with the speed, ownership, and innovation of a scaling tech company. People are at the center of our growth, and we are building a team of motivated, collaborative individuals who take pride in meaningful work and tangible results.

We hold high standards and believe great performance thrives in an environment that is collaborative, energized, and genuinely enjoyable to be part of. This is a high‑ownership culture where strong ideas are welcomed, teamwork matters, and each new hire plays a meaningful role in shaping the organization we are becoming.

Stem Wave is seeking a Quality Engineer to help drive medical device quality and compliance initially by supporting our current design and development project, and eventually future manufacturing and postmarket activities. This is a hands‑on role working side by side with the Engineering team, which will focus on the execution and maintenance of design documentation, risk management efforts, traceability matrices, design verification protocols and reports, and the structure of the project Design and Development File.

The role is execution‑focused and will work closely with QA leadership and the Engineering Team.

• Contribute to design and development process: requirements traceability, verification planning, design transfer readiness, and DDF/MDF documentation.
• Execute risk management activities:
  Hazards Analysis, FMEAs including DFMEA PFMEA, and ensure alignment to ISO 14971 across lifecycle phases.
• Support design verification validation (V&V) activities by working closely with the Engineering Team on planning, documentation, and change control.
• Drive verification/validation (V&V) for processes and equipment (IQ/OQ/PQ), including protocol/report contributions and objective evidence review.
• Help lead adoption of Greenlight Guru Ultralight eQMS, including implementing requirements traceability matrices, risk management activities, and document control and change management.
• Implement & Improve the QMS: author/revise SOPs and Templates; contribute to internal audits and readiness for future external audits.
• Support supplier quality: draft incoming inspection plans, SCARs, and change control creation and review for purchased components and assemblies.
• Enhance production quality: implement sampling plans (ANSI/ASQ Z1.4), IQ/OQ/PQ, GR& R/MSA, and in‑process controls and quality testing.
• Lead CAPA & Nonconformance workflows: triage, root cause investigations, corrective/preventive actions, effectiveness verification, and timely closure.

• Bachelor’s degree in engineering or related technical field.
• 3–5 years of quality engineering experience in medical devices (Class II preferred).
• Knowledge of FDA QMSR 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience with design quality assurance, working as the Quality representative on cross‑functional project teams in a fast‑paced development environment.
• Hands‑on experience leading risk management, requirements traceability, and design verification and validation activities and documentation.
• Robust documentation, rigor, and experience with Greenlight Guru Ultralight eQMS.
• Strong attention to detail and ability to manage multiple documentation streams in parallel.
• Demonstrated success managing CAPA, closing NCRs, and writing verification and validation protocols and reports.
• Proficiency with statistics for quality, including sampling plans for…