Job Overview

The Quality Systems Supervisor is responsible for overseeing and maintaining the site Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, customer expectations, and internal procedures. This role leads Quality Systems activities including document control, training compliance, CAPA coordination, internal and external audits, management review processes, and continuous improvement initiatives. The position partners cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, and Operations to maintain inspection readiness and promote a culture of compliance and operational excellence.

Job Requirements

•Lead and maintain the site Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and applicable regulatory requirements.
•Supervise Quality Systems personnel and support employee development, coaching, and performance management.
•Oversee document control processes including creation, review, approval, revision, distribution, and archival of quality documentation.
•Ensure training systems are effectively maintained and that employee training compliance metrics are monitored and achieved.
•Coordinate and monitor CAPA activities to ensure timely investigations, effectiveness checks, and closure.
•Lead internal audit programs and support external audits from customers, corporate, and regulatory agencies.
•Coordinate Management Review activities including KPI collection, trend analysis, action tracking, and presentation preparation.
•Support change control activities and ensure proper implementation and documentation within the QMS.
•Drive continuous improvement initiatives focused on compliance, process effectiveness, and system efficiency.
•Monitor Quality Systems metrics and escalate compliance risks or overdue activities appropriately.
•Support inspection readiness activities and regulatory compliance initiatives.
•Collaborate with cross-functional teams to improve procedures, workflows, and quality system effectiveness.
•Ensure data integrity and compliance with internal procedures and applicable regulations.

What your background should look like

Qualifications
•Bachelor’s degree in Engineering, Life Sciences, Quality, or related discipline.
•Minimum 4 years of experience in Quality Systems within a regulated industry (medical device preferred).
•Previous supervisory or team leadership experience preferred.
•Strong knowledge of ISO 13485, FDA QSR, CAPA systems, document control, training systems, and audit management.
•Experience supporting regulatory and customer audits.
•Strong organizational, communication, and problem-solving skills.

Knowledge & Skills
•Quality Management Systems (QMS)
•Document Control & Training Systems
•CAPA Management
•Internal & External Audit Coordination
•Management Review Processes
•Continuous Improvement
•Regulatory Compliance
•Cross-functional Leadership
•Risk-based Thinking
•Data Analysis & KPI Management

Preferred Qualifications
•ASQ Certification (CQE, CQA, or equivalent) preferred.
•Lean Six Sigma certification desirable.
•Advanced English proficiency preferred.

Competencies