The
Quality Engineer is responsible for ensuring an efficient and compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. This individual will operate within a small, collaborative and highly driven team focused on improving patient care and saving lives.
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.
- Supports supplier quality activities including supplier qualification, monitoring of supplier performance, and maintenance of the approved supplier list (ASL) in accordance with QMS requirements.
- Supports eQMS implementation activities including data migration, validation support, user acceptance testing until go-live, serving as one of the key liaisons between the organization and the eQMS vendor.
- Reviews and analyzes QMS metrics and performance indicators, preparing reports to identify trends, nonconformances, and opportunities for continuous improvement.
- Assists in the development, implementation, and revision of QMS procedures, SOPs, work instructions, and quality documentation to maintain compliance with applicable standards and regulations.
- 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 objective
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.
- ASQ-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
