Quality Engineer

Responsibilities

• Act as a Quality subject matter expert supporting the development of sterile, single-use medical devices, with ownership of packaging, sterile barrier systems, sterilization, and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements.
• Support risk management activities in accordance with ISO 14971, including identification, analysis, mitigation, and documentation of risks throughout the design lifecycle within the Risk Management File.
• Support the development of Use, Design, and Process FMEAs to systematically identify and address potential failure modes and ensure appropriate risk controls are implemented.
• Support design verification and validation activities, including development, review, and approval of test plans, protocols, and reports, with a focus on compliance testing for biocompatible, sterile, single-use consumable products (e.g., ISO 10993, IEC 60601-1, packaging and sterilization‑related testing).
• Support the development and maintenance of the Usability Engineering File in accordance with IEC 62366 and applicable regulatory requirements.
• Support supplier qualification and process validation activities, including review of supplier documentation and quality outputs.
• Support test and inspection equipment evaluation, method development, and qualification activities as required.
• Support manufacturing transfer activities, including creation and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ).
• Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation to ensure alignment with validated processes and design requirements.

• Support the collection, analysis, and trending of quality and performance metrics to identify opportunities for improvement.
• Propose, lead, and support Corrective and Preventive Actions (CAPAs) to address systemic issues and ensure effective resolution.
• Lead and/or participate in product complaint investigations, including root cause analysis and documentation of findings.
• Support the disposition of nonconforming material, including collaboration with cross‑functional teams to determine appropriate actions.
• Support other quality‑related activities as assigned.

• Bachelor’s degree in Engineering, Biomedical Engineering, or Life Sciences.
• 5–7 years of experience as a Quality Engineer or Design Quality Engineer in the medical device industry, supporting development and sustaining activities for sterile, single‑use consumables and packaging.
• Hands‑on experience with ISO 10993‑1, ISO 11607‑1, and ISO 11135 preferred.
• Working knowledge of QMSR, ISO 13485, ISO 14971, IEC 62366, and MDD/MDR requirements.
• Experience with applied statistics, including use of Minitab or equivalent statistical software.
• Demonstrated experience in CAPA, nonconformance management, and complaint investigations.
• Experience supporting De Novo and/or PMA submissions is preferred.
• Strong verbal and written communication skills, with the ability to author clear, concise, and technically sound procedures, protocols, analyses, and reports, and to collaborate effectively with internal and external stakeholders.