Quality Systems Specialist

Your challenge

Responsibility:
The Quality System Specialist is responsible for working within the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality. This role focuses on performing activities within the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, and audit programs.
•    Electronic Quality Document System (eQMS) Management:
o    Coordinate 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    Initiate and coordinate use of the CAPA process, ensuring thorough investigation, root cause analysis, and timely completion of corrective actions.
o    Participate on 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    Initiate and coordinate 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.
•    Nonconformance (NCR):
o    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.
o    Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause.
o    Analyze deviation trends and provide insights into continuous improvement initiatives. 

Your Profile

Job Requirements:
•    Bachelor’s degree in Engineering, Life Sciences, or related field.
•    3-5 years of experience in the medical device industry, with a strong background in QMS, CAPA, audits, and regulatory compliance (ISO 13485, 21 CFR 820).
•    Experience working in with an electronic Quality Management software. Experience with implementation MasterControl preferred.  
•    Strong knowledge of FDA and ISO quality standards and the ability to lead regulatory compliance initiatives.