Job Description

Position Title: Quality Engineer

Location: Boston, Massachusetts

Duration: Long-Term Project

Key Responsibilities:

• Design Assurance & Risk Management:
• Lead design assurance activities for new and existing medical devices, including risk management per ISO 14971. Participate in design reviews to ensure product safety, reliability, and compliance with internal and regulatory standards.
• Test Method Development & Validation:
• Develop, validate, and implement test methods, inspection procedures, and sampling plans to verify product and process performance. Ensure accuracy and repeatability in test methodologies.
• Product Launch & Design Transfer:
• Support new product introduction (NPI) activities, ensuring smooth design transfer from R&D to manufacturing. Partner with operations and process engineering to validate manufacturing processes and establish robust control plans.
• Change Control & Quality Documentation:
• Manage change control processes for product and process modifications. Draft, review, and maintain SOPs, work instructions, and technical documentation to ensure compliance with company and regulatory requirements.
• Supplier Quality & Audits:
• Collaborate closely with suppliers to maintain component and material quality. Participate in supplier qualification, monitoring, and audit activities. Support internal and external audits, CAPA, and continuous improvement initiatives.
• Continuous Improvement:
• Identify opportunities to enhance product quality and manufacturing efficiency. Apply root cause analysis, risk-based thinking, and lean principles to drive corrective and preventive actions.

Qualifications & Requirements:

• Bachelor’s or master’s degree in engineering, biomedical engineering, mechanical engineering, or a related technical discipline.
• 3–7 years of experience in medical device quality engineering, design assurance, or product development support.
• Hands-on experience with catheters, guidewires, or other Class II/III medical devices is highly desirable.
• Strong working knowledge of ISO 13485, 21 CFR Part 820 (QSR), ISO 14971, and other applicable global medical device regulations.
• Proven ability to interpret engineering drawings, specifications, and test data.
• Excellent analytical, documentation, and problem-solving skills with strong attention to detail.
• Effective communication and collaboration skills with cross-functional and supplier teams.

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