Quality Engineer II

About the role

Resonetics is seeking a Quality Engineer II to provide customer‑ and factory‑facing quality support for its advanced medical‑device micro‑manufacturing operations. The role bridges Resonetics, its customers, and suppliers, ensuring smooth transition and sustainment of laser manufacturing processes while maintaining compliance with ISO 13485 and 21 CFR 820.

Key responsibilities

• Liaise with customer quality personnel to resolve issues, manage complaints, and disseminate quality report cards.
• Generate process deviations, customer change notices, validation protocols and reports.
• Assist with troubleshooting production processes and lead the PDP (Product Development Process) effort.
• Develop and maintain metrology equipment, quality/control plans, and PFMECAs.
• Conduct Gage R&R studies, resolve corrective and preventive actions, and approve non‑conformance dispositions.
• Analyze production and validation data, and drive continual improvement projects.

Required profile

• Minimum 2 years experience in a Quality Engineering role within a regulated or start‑up environment.
• Demonstrated technical writing and communication abilities.
• Working knowledge of statistical software and/or Minitab.
• Bachelor’s degree in a relevant engineering or scientific discipline.

Required skills

• Lean Six Sigma methodology (Green or Black Belt preferred).
• Process validation and verification techniques.
• Gage R&R implementation.
• ISO 13485 and 21 CFR 820 compliance knowledge.
• Statistical analysis tools (e.g., Minitab).
• Metrology equipment development.