Position: Quality Assurance 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.
Key ResponsibilitiesEnsure 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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