Associate Quality and Compliance Manager - Medical Device and Human Tissue

Join an ophthalmic medical device company that has developed the first natural-tissue corneal allograft. The Associate Quality and Compliance Manager (AQCM) is responsible for ownership, oversight, and continuous improvement of the Quality Management System (QMS) and for ensuring worldwide regulatory compliance of Allotex products and operations. This role provides hands-on quality and regulatory leadership across manufacturing, suppliers, distributors, and post-market activities.

The AQCM serves as a quality decision-maker, escalation point, and system owner, typically bringing a minimum of three years of relevant Quality Assurance experience in regulated medical device and/or human tissue environments.

• Own and manage core QMS processes including nonconformances, CAPAs, change control, complaints, and document control
• Provide daily quality and regulatory support to manufacturing, ensuring compliance with cGMPs and internal procedures
• Lead and support investigations into nonconformances, deviations, and complaints, including root cause analysis and corrective actions
• Plan, conduct, and respond to internal, supplier, distributor, and regulatory audits and inspections
• Oversee supplier and distributor qualification, monitoring, quality agreements, and regulatory readiness
• Review and approve quality records, investigations, CAPAs, and change controls
• Monitor, trend, and report QMS and regulatory compliance metrics at Management Review
• Drive continuous improvement initiatives across manufacturing, quality, and regulatory systems
• Support and maintain calibration and preventive maintenance programs
• Ensure inspection, validation, and process controls meet regulatory and internal requirements
• Support preparation, maintenance, and updates of regulatory submissions and technical documentation for global markets
• Maintain awareness of worldwide regulatory requirements and assess impact to procedures, labeling, and distribution
• Support regulatory inspections, health authority interactions, and responses to regulatory inquiries
• Ensure global post-market surveillance, complaint handling, and vigilance reporting requirements are met
• Provide mentoring and guidance to Quality Operations personnel
• Serve as backup owner for all quality system processes as needed
• Ensure compliance with ISO 13485, 21 CFR 820, 21 CFR 1271, EU MDR, and other applicable international regulations

Experience:

• Bachelor’s degree in science, engineering, or related technical field (Master’s degree preferred)
• Minimum of 3 years of Quality Assurance experience in regulated medical device and/or human tissue environments
• Demonstrated experience supporting worldwide regulatory compliance and audits
• Strong working knowledge of ISO 13485, 21 CFR 820, 21 CFR 1271, EU MDR, and applicable international standards
• Experience with audits, CAPA systems, supplier management, complaints, and post-market activities