Quality Systems Specialist III (Contractor)

Quality Systems Specialist III (Contractor)

The Quality Systems Specialist III (contractor) will be responsible for maintaining and enhancing the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA, EU MDR, and other relevant standards. This role focuses on measuring QMS effectiveness, leading continuous improvement initiatives, and managing CAPAs, audits, and regulatory inspections.

Key Responsibilities:

• Oversee day-to-day management of QMS to ensure compliance with FDA, ISO 13485, and EU MDR.
• Lead Quality Management Reviews (QMR), preparing data, presentations, and meeting agendas.
• Drive continuous improvement in the QMS by identifying and implementing enhancements.
• Prepare for and support internal/external audits and regulatory inspections.
• Lead CAPA processes, from initiation to root cause analysis and implementation of solutions.
• Manage non-conformance reports and ensure effective issue resolution.
• Collaborate with R&D, Manufacturing, Regulatory, and Supply Chain teams to ensure QMS compliance.
• Maintain documentation, SOPs, and records in compliance with internal and global standards.

Qualifications:

• Bachelor’s degree in Engineering, Nursing, or a related field.
• Minimum 5 years of experience in Quality Assurance, with 3+ years in QMS management for medical devices.
• Expertise in ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulations.
• Strong communication skills, problem-solving abilities, and a proactive approach to continuous improvement.