Quality Engineer

Quality Assurance Manager

Position located in Boston, MA

Responsibilities:

• Provide quality oversight and support for combination product development and commercialization activities.
• Maintain and support the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and other applicable FDA and international regulations.
• Partner with R&D, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure quality requirements are incorporated throughout the product lifecycle.
• Support Design Control activities, including Design History File (DHF) documentation, design reviews, design verification and validation, and design changes.
• Assist with risk management activities, including product risk assessments, FMEAs, and implementation of risk controls.
• Review and approve quality and technical documentation, specifications, protocols, reports, and change controls.
• Support investigation of nonconformances, deviations, complaints, and CAPAs, including root-cause analysis and effectiveness checks.
• Participate in supplier qualification, supplier quality activities, and oversight of external manufacturing partners.
• Support internal and external audits and assist with preparation of responses to audit findings.
• Provide quality guidance to cross-functional project teams and help identify potential compliance risks early in the development process.
• Contribute to continuous improvement initiatives related to product quality, processes, and the overall QMS.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field.
• 3+ years of experience in Quality Engineering within medical device, pharmaceutical, biotechnology, or combination product environments.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 4.
• Experience with Design Controls, risk management, CAPA, nonconformance investigations, and change control.
• Experience working in a regulated GMP environment preferred.
• Strong technical writing, documentation, problem-solving, and communication skills.
• Ability to work effectively with cross-functional teams in a fast-paced product development environment.