Senior Quality Management System; QMS) Quality Engineer
Listed on 2026-10-16
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Position Summary
The Senior Quality Management System (QMS) Quality Engineer is a technical leader responsible for maintaining, improving, and ensuring the effectiveness of the Company's Quality Management System (QMS) and electronic Quality Management System (eQMS). This individual partners closely with Quality, Regulatory Affairs, R&D, Manufacturing, Operations, Supply Chain, and Program Management to ensure compliance with applicable regulatory requirements and industry standards throughout the product lifecycle.
The Senior QMS Quality Engineer will lead quality system initiatives including CAPA, change control, document control, training, audits, supplier quality, management review, risk management, and continuous improvement activities. This role will serve as a key quality systems resource supporting product development, verification, validation, commercialization, and post-market activities within a regulated medical device environment.
Diagnostics, point-of-care diagnostics, molecular diagnostics, or IVD experience is strongly preferred.
Key Responsibilities Quality Management System Leadership- Maintain and continuously improve the Quality Management System (QMS) in accordance with applicable regulatory requirements and industry standards.
- Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, MDSAP, Health Canada Medical Device Regulations, and internal procedures.
- Support development, implementation, and continuous improvement of quality policies, procedures, and processes.
- Monitor quality system performance and identify opportunities for improvement.
- Support organizational readiness for regulatory inspections, certification audits, and commercialization activities.
- Serve as a primary administrator and business process owner for the electronic Quality Management System (eQMS).
- Configure and maintain workflows associated with document control, training, CAPA, nonconformance, change control, complaints, supplier quality, and audits.
- Support eQMS implementations, upgrades, enhancements, validation activities, and data migrations.
- Develop reports, dashboards, and metrics to monitor quality system effectiveness.
- Partner with IT and software vendors to maintain compliant and efficient system functionality.
- Drive user adoption and continuous improvement of eQMS capabilities.
- Lead and facilitate CAPA, nonconformance, deviation, and change control processes.
- Conduct and support root cause investigations using structured problem-solving methodologies.
- Ensure corrective and preventive actions are appropriately implemented and verified for effectiveness.
- Monitor quality system trends and identify systemic improvement opportunities.
- Plan, conduct, and support internal audits.
- Participate in supplier audits, customer audits, certification audits, and regulatory inspections.
- Manage audit findings and ensure timely closure of corrective actions.
- Maintain a state of continuous audit readiness across the organization.
- Support document lifecycle management including creation, review, approval, revision, and archival.
- Ensure training requirements are established and maintained.
- Monitor training compliance and effectiveness.
- Support development and maintenance of quality system documentation and records.
- Support design control activities throughout product development.
- Participate in design reviews, verification, validation, and design transfer activities.
- Support implementation and maintenance of risk management processes in accordance with ISO 14971.
- Review design and process changes for quality system and regulatory impact.
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