Quality Compliance Specialist II

Quality Compliance Specialist II– Medical Device

The Quality Compliance Specialist supports quality assurance activities in alignment with FDA, European MDD/MDR, and ISO regulations. Working under supervision, this role focuses on nonconformance (NCR) processes, data analysis, internal and external audits, service order records, supplier files, and monitoring key process metrics. The position requires frequent use of established industry practices, techniques, and standards to help maintain and improve the quality management system.

• Participate in quality system activities and support internal and external audits in compliance with FDA, European MDD/MDR, and ISO regulations.
• Coordinate audit-related activities, including preparing documents, tracking audit requests, taking notes, scheduling conference rooms, and setting up communication channels.
• Interface with subject matter experts to clarify and respond to audit requests and ensure timely completion of audit actions.
• Work cross-functionally with other teams to track and manage NCR, rework, and deviation activities from initiation through closure.
• Assist with identification, segregation, investigation, and final disposition of affected product associated with NCRs, rework, and deviations.
• Identify and help implement continuous improvement activities within the quality management system (QMS).
• Maintain quality records in accordance with established procedures and regulatory requirements.
• Initiate and maintain supplier files on the approved supplier list, ensuring documentation is complete, accurate, and current.
• Gather and update supplier information as needed to ensure supplier files remain in compliance with internal supplier procedures.
• Manage Service Order Requests (SOR), including maintaining accurate records of SOR activities.
• Ensure NCR materials associated with SORs are managed to comply with 30-day post-receipt requirements.
• Maintain complete records of all SOR repairs and the costs associated with those repairs.
• Develop, implement, and maintain SOR data logs to support analysis and trending of service-related activities.
• Compile data and prepare presentations for periodic reviews of quality systems such as SORs and cost per SOR.
• Collaborate with cross-functional teams to compile and generate periodic quality reports in a timely manner.
• Work with cross-functional teams to track and ensure quality objectives established during management reviews are met.
• Support organizational goals, objectives, policies, procedures, QSR, and applicable FDA regulations through daily work activities.
• Perform other quality-related duties as assigned to support the overall effectiveness of the quality management system.

• Bachelor's degree and a minimum of 2 years of related experience in the medical device industry.
• Experience working within FDA and ISO-regulated environments, including familiarity with audits, NCR processes, and CAPA activities.
• Ability to compile and analyze data, interpret trends, and present information clearly to stakeholders.
• Competent document writing skills with strong attention to detail and accuracy.
• Excellent written and verbal communication skills for effective interaction with cross-functional teams and subject matter experts.
• Basic knowledge of current Good Manufacturing Practices (cGMP), FDA 21 CFR 820 Quality System Regulation (QSR), and ISO or other quality systems.
• Ability to understand and follow QMS procedures, including standard operating procedures (SOPs) and test methods.
• Proficiency with computer-based applications such as MS Word and MS Excel, and the ability to work with other office productivity tools.
• Strong time management skills and the ability to prioritize and multi-task in a fast-paced environment.
• Ability to operate effectively both as part of a team and independently, while demonstrating flexibility to changing requirements.
• Hands-on experience in quality assurance, quality control, or compliance within the medical device sector.
• Working knowledge of NCR and quality system processes, including data entry and documentation in quality systems.

• Experience with FDA and…