Overview
Quality Engineer Jobs in Newton, USA at Comrise
- 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.
Sustaining Activities
- 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.
Required/Preferred skills to have for the success of this role:
- 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.
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Title: Quality Engineer
Company: Comrise
Location: Newton, USA
Category:
