Quality Assurance Engineer

Key Responsibilities

• Supports and maintains Quality Management System (QMS) processes including audits, complaints, CAPA, and change control activities to ensure compliance with regulatory and company requirements.
• Owns and manages the Document Control process, including DCO routing, version control, and change order processing, ensuring timely and compliant document lifecycle management.
• Manages the training program including training matrix maintenance, training record management, and rollout of procedure-based and role-based training to ensure organizational compliance.
• Serves as a liaison between the organization and the eQMS vendor for eQMS implementation activities such as data migration, validation support, user acceptance testing until go-live.
• Reviews and analyzes QMS metrics and performance indicators, preparing reports to identify trends, nonconformances, and opportunities for continuous improvement.
• Supports supplier quality activities including supplier qualification, monitoring of supplier performance, and maintenance of the approved supplier list (ASL) in accordance with QMS requirements.
• Participates in risk assessment activities and supports the development of mitigation plans to minimize quality and compliance risks.
• Contributes to continuous improvement initiatives by identifying process enhancements and supporting implementation of quality system improvements.
• Collaborates cross-functionally to resolve quality issues, support investigations, and implement corrective and preventive actions.
• Supports internal and external audits by preparing documentation, coordinating audit activities, and assisting with responses to audit observations.
• Maintains effective working relationships with internal teams and external stakeholders to support quality objectives and compliance activities.
• Proactively maintains knowledge of industry standards, regulatory requirements, and company quality procedures.
• Occasional travel for team meetings, conferences and vendor visits.
• Performs other quality system duties as assigned in support of company quality objectives.

Qualifications

• Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.
• Experience & Technical Expertise: 3+ years of experience in FDA-regulated and/or ISO 13485 medical device manufacturing or quality environments.
• Working knowledge of Quality Management Systems (QMS), including document control, training, CAPA, audits, change control, and nonconformance processes.
• Experience supporting internal and external audits and maintaining compliance with applicable regulatory and quality standards.
• Familiarity with CAPA processes, root cause analysis tools, and continuous improvement methodologies.
• Experience reviewing quality data, metrics, and KPIs to identify trends and support decision-making.
• Ability to work collaboratively with cross-functional teams and communicate effectively with internal and external stakeholders.
• Experience maintaining training records, training matrices, or learning management systems is preferred.
• AQSC-CQE, ISO 13485, or Lead Auditor certification is a plus.
• Proficient in Microsoft Office applications and quality documentation systems.
• Hands-on experience with eQMS platforms strongly preferred; experience participating in an eQMS implementation or migration is a plus.
• Experience with supplier qualification, approved supplier list (ASL) management, or supplier audits preferred.
• Self-motivated, able to accomplish multiple assignments simultaneously.
• Strong organizational and problem-solving skills.
• Detail-oriented.