Quality Assurance Manager - Medical Device

Responsibilities

• Lead the assigned facility's medical device Quality Management System activities supporting contract manufacturing, kitting, packaging, labeling, storage, fulfillment, returns support where approved, and distribution operations.
• Ensure work is performed in accordance with approved client specifications, work instructions, quality plans, statements of work, quality agreements, and applicable regulatory requirements.
• Maintain operation-specific Quality Management System controls aligned with FDA 21 CFR Part 820/QMSR requirements, ISO 13485 where applicable, customer requirements, and company procedures.
• Serve as the site's primary quality contact for client quality representatives, regulatory inquiries, audits, inspections, complaint support, CAPA activities, recall support, and inspection readiness efforts.
• Manage and continuously improve medical device quality processes, records, controls, and documentation to support compliant, traceable, and inspection-ready operations.
• Oversee product identification, traceability, labeling, packaging, and recordkeeping controls throughout receipt, production, storage, fulfillment, shipment, and approved returns processes.
• Lead product hold, quarantine, stop-ship, nonconforming product, investigation, escalation, and disposition activities in accordance with approved procedures and customer requirements.
• Identify nonconformances, quality risks, regulatory concerns, and process gaps, and ensure appropriate escalation, investigation, corrective action, and preventive action activities are implemented.
• Manage site-level deviation, nonconformance, CAPA, risk assessment, corrective action, and continuous improvement processes for medical device operations.
• Support complaint investigations, recalls, corrections, removals, field actions, and other quality events by providing required records, traceability information, and operational support.
• Ensure personnel are appropriately trained and qualified for medical device operations, maintain required training documentation, and verify training effectiveness through audits, observation, and performance review.
• Support process risk assessments, validation and revalidation activities, and ongoing maintenance of validated systems, equipment, processes, and quality controls used in regulated operations.
• Maintain calibration, qualification, maintenance, environmental monitoring, and storage control records to support compliant medical device operations.
• Prepare for and support client, certification, and regulatory audits and inspections by maintaining inspection-ready processes, records, and personnel resources.
• Develop and monitor quality metrics, evaluate performance trends, support continuous improvement initiatives, and drive actions that strengthen quality, compliance, and operational performance.
• Partner with operations, inventory, engineering, IT/WMS, client quality, regulatory, and site leadership teams to implement and sustain compliant medical device processes and customer requirements.
• Ensure supplier, subcontractor, and outsourced process quality requirements are effectively managed and participate in site leadership, readiness reviews, and projects supporting medical device customer commitments.
• Perform other quality, compliance, audit, inspection readiness, and client support duties as assigned.

Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related field required.
• Minimum 5 years of progressive quality experience in medical device, regulated and/or contract manufacturing, logistics, distribution, or a comparable FDA-regulated environment.
• Equivalent combinations of education and experience may be considered.
• Site quality leadership experience in a warehouse, fulfillment, kitting, packaging, labeling, or contract manufacturing environment is strongly preferred.
• Experience with FDA 21 CFR Part 820/QMSR, ISO 13485, medical device quality systems, validation, complaint support, CAPA, nonconformance, traceability, labeling/packaging controls, and client or regulatory audits is strongly preferred.
• ASQ certification, ISO 13485 auditor certification or comparable professional credential is preferred.

Skills