Design Quality Engineer

Location:

Newton, MA Salary:

$45.00 USD Hourly - $52.00

USD Hourly Description:

Title :

Design Quality Engineer Location:

Auburndale, MA 02466 Contract | 1+ Years Job Description 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 make clear, concise, and technically sound procedures, protocols, analyses, and reports, and to collaborate effectively with internal and external stakeholders. New Product Development 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. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

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