Position Summary:

The Quality Manager is responsible for leading and managing the quality assurance and quality control functions for our in vitro diagnostic (IVD) medical device product lines. This role ensures that products are developed, manufactured, and distributed in compliance with applicable regulatory requirements (e.g., FDA QSR, ISO 13485, IVDR) and internal quality standards. The Quality Manager will play a key role in maintaining and continuously improving the quality management system, driving product and process quality, and supporting regulatory submissions and audits.

Key Responsibilities:

• Oversee the implementation, maintenance, and continuous improvement of the Quality Management System in compliance with ISO 13485, 21 CFR Part 820, and EU IVDR.
• Lead and manage quality assurance and quality control personnel.
• Review and approve quality documents, including SOPs, batch records, deviations, CAPAs, nonconformances, and validation protocols/reports.
• Support design control activities and risk management (ISO 14971) for new product development and changes to existing products.
• Manage internal and external audits, including FDA inspections, notified body audits, and supplier audits.
• Monitor and report quality metrics and key performance indicators (KPIs).
• Support the complaint handling and post-market surveillance processes.
• Ensure proper document control, training, and change control practices are in place and followed.
• Collaborate with cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Supply Chain to ensure product and process compliance.
• Serve as the Quality representative on project teams, providing guidance on regulatory and quality requirements.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or technical discipline; advanced degree preferred.
• Minimum of 5–8 years of quality experience in the medical device or IVD industry.
• Strong knowledge of QSR (21 CFR Part 820), ISO 13485, and EU IVDR requirements.
• Proficiency in quality tools and methodologies (e.g., CAPA, FMEA, root cause analysis, Six Sigma).
• ASQ certifications (e.g., CQA, CQE) a plus.