SUMMARY

The Medical Device Quality Assurance Manager leads the assigned facility's quality program supporting medical device contract manufacturing, kitting, packaging, labeling, storage, fulfillment, distribution, and related operations. This role is responsible for maintaining site-level Quality Management System (QMS) controls in compliance with applicable FDA 21 CFR Part 820/QMSR requirements, ISO 13485 where applicable, customer requirements, and internal procedures. The position serves as the site's primary quality resource, partnering with operations, customers, and cross-functional teams to ensure product quality, traceability, regulatory compliance, audit readiness, and continuous improvement across medical device operations. The role provides oversight of quality records, investigations, nonconformance and CAPA processes, complaint and recall support, training, and inspection readiness activities to support safe, compliant, and efficient operations.

ESSENTIAL DUTIES AND 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.

QUALIFICATONS
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.

Education & Experience:

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.

Knowledge, Skills, and abilities:

Strong knowledge of medical device quality systems, site-level QMS controls, DHR/batch records, traceability, WMS or regulated software records, process validation, change control, complaint escalation, recall support, CAPA, nonconformance, and audit/inspection readiness. Able to interpret regulatory, client, and procedural requirements and convert them into practical site controls. Fast learner with strong project management skills, including prioritizing work, developing action plans, tracking milestones, meeting deadlines, communicating risks early, and coordinating cross-functional resources. Excellent communication, attention to detail, judgment, risk assessment, data analysis, root cause problem-solving, and cross-functional leadership skills. Demonstrates a passion for quality and continuous improvement by engaging employees, coaching teams, promoting accountability, and strengthening quality culture. Maintains a professional, solutions-oriented attitude and builds effective relationships with clients, auditors, regulators, operations, IT, leadership, and other stakeholders while modeling company values.

PHYSICAL/ENVIRONMENTAL DEMANDS

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Activity Level:

While performing the duties of this Job, the employee is regularly required to walk, squat, use hands to finger, handle, or feel. Must be able to see clearly and talk/hear. The employee must occasionally lift and/or move up to 25 pounds unassisted.

Travel:

Ability to travel occasionally for client audits, supplier audits, regulatory inspection support, project implementation, training, emergency response, or company meetings related to the assigned facility’s medical device operations.

Working Conditions:

This site-level position works primarily in the assigned facility’s office, warehouse, fulfillment, kitting, packaging, labeling, storage, and distribution environments. The role may be exposed to ambient warehouse conditions, varying seasonal temperatures, noise, powered industrial truck traffic, palletized materials, packaging lines, inspection areas, quarantine or hold areas, and other operational conditions typical of a regulated warehouse or contract manufacturing environment.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.