Senior Quality Systems Specialist

Your challenge

Oversee 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.

• Oversee the implementation, maintenance, and continuous improvement of the eQMS to ensure regulatory compliance.
• Coordinate document control, including the review, approval, and maintenance of SOPs and controlled documents.
• Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross-functional integration.

• Oversee the CAPA process, ensuring thorough investigation, root cause analysis, and timely completion of corrective actions.
• Participate and/or lead CAPA Review Board to discuss ongoing issues, drive timely closure, and communicate CAPA metrics to senior management.
• Conduct and review CAPA effectiveness checks, ensuring corrective actions are adequate and sustainable.

• Coordinate change control activities, ensuring that changes are documented, evaluated for risk, and implemented in compliance with QMS.
• Provide guidance and support for change control processes across departments to ensure consistency and effectiveness.

• Ensure that quality system processes comply with FDA, ISO 13485, and ISO 9001 requirements.
• Identify and implement continuous improvement initiatives to enhance QMS efficiency and effectiveness.
• Facilitate training sessions for staff on QMS elements, CAPA processes, audits, and change control.

• Facilitate and lead NCR investigations involving multiple investigation areas. Work with various departments, including manufacturing, packaging, quality control, maintenance, engineering, and supply chain, to conduct investigations, determine root cause and implement improvements.
• Perform investigations using structured root cause analysis tools (fishbone, 5 Why’s, etc.) and partner with team members to determine “true” root cause.
• Analyze deviation trends and provide insights into continuous improvement initiatives.

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 3 years of experience in change control within a regulated environment, ideally in medical devices or pharmaceuticals.
• Strong knowledge of FDA QSR, ISO 13485, and cGMP requirements.
• Experience with electronic Quality Management Systems (eQMS) and document control.