Quality Engineer

Position Summary

StermWave is seeking a Quality Engineer to support our current design and development project and eventually future manufacturing and postmarket activities. This role involves hands-on work with the Engineering team, focusing on design documentation, risk management, traceability matrices, design verification protocols, and reports.

What You'll Do

• 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.

What We’re Looking For

• 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 verification and validation, and inspection and tools such as Minitab and advanced Excel.
• Excellent cross-functional communication; comfortable partnering with Engineering, Operations, and Regulatory.

Benefits

• Unlimited Paid Time Off
• 14 Paid Company Holidays
• Comprehensive Health Coverage: Medical, dental, and vision insurance - 100% employer paid
• HSA Option: Add a Health Savings Account to a high-deductible health plan
• Paid Parental Leave
• Employee Referral Program: Earn rewards for helping us grow our team

Why Join Us

• Leadership: Help practices and medical centers adopt groundbreaking technology that empowers patients and allows practitioners to offer versatile treatment options
• Exposure: Work closely with key decision-makers in the healthcare space, expanding your network and influence in a rapidly growing industry
• Growth: Join an energetic and innovative culture where your ideas are valued. You’ll have the opportunity to contribute to company growth, take on new projects, and further your career
• At StemWave, we're not just building devices, we're building a movement. Join us and be a key contributor to our growth and success.