We're seeking a hands-on and detail-oriented Quality Engineer to join our growing Quality Assurance and Regulatory Affairs team. The ideal candidate will have a strong engineering background with experience across the product lifecycle—from design to manufacturing—within the medical device industry. The title of Senior Quality Engineer is available for candidates with deeper experience and demonstrated leadership.

Role/Responsibilities

• Partner with R&D to define product requirements and release criteria; support design reviews and technical documentation
• Lead risk management activities (FMEA/DFMEA/PFMEA) and maintain traceability throughout the design process
• Author, maintain, and execute design verification and validation (V&V) protocols and reports; lead formal V&V testing
• Execute and document intended-use validations and computer system validations
• Draft, revise, and maintain SOPs aligned with FDA QMSR and ISO 13485; support internal audits and monitor quality metrics
• Contribute to regulatory submissions (e.g., 510(k)); prepare Letters to File, labeling, and supporting documentation; ensure alignment with applicable regulations and standards
• Oversee supplier qualification; conduct supplier audits; drive SCARs and supplier improvement actions; communicate quality issues with suppliers
• Develop inspection plans; support inventory control, equipment/tool maintenance/calibration, and process validations (IQ/OQ/PQ)
• Collaborate across Operations, Manufacturing, and Supply Chain to communicate risks, mitigations, and timelines

Requirements

• Bachelor’s degree in Engineering or a related technical field
• 2–4 years of quality engineering experience in the medical device industry (additional experience considered for Senior title)
• Working knowledge of FDA QMSR, ISO 13485, and ISO 14971; experience with lifecycle documentation and QMS development in regulated environments
• Preferred familiarity with 510(k) submissions and/or EU MDR technical documentation
• Preferred familiarity with early-stage/startup environments
• Strong technical writing, attention to detail, data-driven problem solving, and excellent communication/stakeholder management
• Strategic and hands-on, collaborative, adaptable, and mission-driven