Quality System Manager

Your challenge

The Quality System Manager is responsible for overseeing the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality. This role focuses on managing the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, and audit programs.
•    Electronic Quality Document System (eQMS) Management:
o    Oversee the implementation, maintenance, and continuous improvement of the eQMS to ensure regulatory compliance.
o    Manage document control, including the review, approval, and maintenance of SOPs and controlled documents.
o    Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross-functional integration.
•    Corrective and Preventive Actions (CAPA):
o    Oversee the CAPA process, ensuring thorough investigation, root cause analysis, and timely completion of corrective actions.
o    Lead the CAPA Review Board to discuss ongoing issues, drive timely closure, and communicate CAPA metrics to senior management.
o    Conduct and review CAPA effectiveness checks, ensuring corrective actions are adequate and sustainable.
•    Change Control:
o    Manage change control activities, ensuring that changes are documented, evaluated for risk, and implemented in compliance with QMS.
o    Provide guidance and support for change control processes across departments to ensure consistency and effectiveness.
•    Quality System Compliance and Continuous Improvement:
o    Ensure that quality system processes comply with FDA, ISO 13485, and ISO 9001 requirements.
o    Identify and implement continuous improvement initiatives to enhance QMS efficiency and effectiveness.
o    Facilitate training sessions and provide mentorship to staff on QMS elements, CAPA processes, audits, and change control.

Your Profile

•    Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
•    5-8 years of experience in the medical device industry, with a strong background in QMS, CAPA, audits, and regulatory compliance (ISO 13485, 21 CFR 820).
•    Proven experience for implementation and maintenance of electronic Quality Management software. Experience with implementation MasterControl preferred.  
•    Demonstrated leadership and project management skills with a track record in quality system management.
•    Strong knowledge of FDA and ISO quality standards and the ability to lead regulatory compliance initiatives.
 

Our Offer