Design Quality Engineer

Location: Newton, MA
Salary: $60.00 USD Hourly - $70.00 USD Hourly
Description: Our client is currently seeking a Design Quality Engineer

Job Title: Design Quality Engineer
Location: Auburndale, MA 02466
Duration: 1 Year Contract

Position Overview We are seeking a Senior Design Quality Engineer (Consumables) to support the development and sustaining of sterile, single-use medical devices. This role will act as a quality subject matter expert, ensuring compliance with applicable standards and quality system requirements. Responsibilities include risk management, verification and validation, supplier qualification, manufacturing transfer, and ongoing quality improvement activities.

Responsibilities

New Product Development

• Provide quality expertise for sterile, single-use medical devices, including packaging, sterilization, and biocompatibility.
• Support risk management activities per ISO 14971 and maintain the Risk Management File.
• Develop and review FMEAs (Use, Design, Process) to identify and mitigate risks.
• Support design verification and validation activities, including compliance testing (ISO 10993, IEC 60601-1, packaging/sterilization).
• Maintain the Usability Engineering File per IEC 62366.
• Support supplier qualification, process validation, and equipment evaluation.
• Assist with manufacturing transfer activities, including DMR/DHR documentation and validation protocols.
• Develop and maintain work instructions, procedures, and inspection documentation.

Sustaining Activities

• Collect and analyze quality and performance metrics to drive improvements.
• Lead or support CAPAs to resolve systemic issues.
• Participate in product complaint investigations and root cause analysis.
• Support disposition of nonconforming material and other quality-related activities.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
• 5-7 years of experience as a Quality Engineer in the medical device industry, with focus on 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 MDR requirements.
• Experience with applied statistics (Minitab or equivalent).
• Strong background in CAPA, nonconformance management, and complaint investigations.
• Experience supporting De Novo and/or PMA submissions preferred.
• Excellent verbal and written communication skills.

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