Job Description

Position: Medical Devices Quality Engineer

Location: Woburn, MA

Experience: 3 5 years
Contract: 12+ Months (Extendable)
Eligibility: US Citizen or Green Card holders only

The Quality Assurance Engineer will support quality systems and compliance activities within the medical device or pharmaceutical environment. This role focuses on regulatory adherence, risk management, documentation, and audit support to ensure products meet global quality and safety standards.

• Ensure compliance with global regulatory requirements including FDA, EU MDR, and applicable international standards

• Support and maintain Quality Management System activities aligned with ISO 13485 and 21 CFR

• Lead and support CAPA investigations, root cause analysis, and effectiveness checks

• Conduct and document risk management activities including FMEA and hazard analysis

• Prepare, review, and approve quality documentation such as SOPs, protocols, reports, and validation records

• Support internal, external, and regulatory audits including preparation and response activities

• Manage supplier quality activities including evaluations, audits, and issue resolution

• Support change control, nonconformance handling, and continuous improvement initiatives

• Collaborate cross-functionally with engineering, manufacturing, validation, and regulatory teams

• 3 5 years of hands-on experience in Quality Engineering within medical device or pharmaceutical manufacturing

• Strong working knowledge of ISO 13485 and FDA 21 CFR requirements

• Proven experience with CAPA, deviation management, and risk management tools

• Experience generating and reviewing quality and validation documentation

• Familiarity with audit processes and regulatory inspections

• Strong documentation, communication, and problem-solving skills

• Exposure to FDA inspections or notified body audits

• Experience with supplier quality management

• Background supporting validation or process qualification activities

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