Quality Assurance Manager - Medical Device

suddath; Duluth (GA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits

401(k) with company match

Weekly pay

Paid Time Off (PTO)

Tuition reimbursement

Job summary

Suddath is seeking a Medical Device Quality Assurance Manager to lead the site quality program supporting contract manufacturing, kitting, packaging, labeling, storage, and distribution. The role ensures QMS controls are compliant with FDA and customer requirements and drives continuous improvement.

The position partners with operations, clients, and cross-functional teams to ensure product quality, traceability, audit readiness, and trained personnel.

Responsibilities

• Lead medical device QMS activities across manufacturing, kitting, packaging, storage, and distribution.
• Ensure work aligns with client specs, instructions, quality plans, and regulatory requirements.
• Maintain QMS controls per FDA 21 CFR Part 820/QMSR and ISO 13485 where applicable.
• Act as site quality contact for client reps, regulators, audits, and CAPA.
• Oversee deviations, nonconformances, CAPA, risk assessments, and corrective actions.
• Support audits, recall preparedness, training, and inspection readiness.

Job description

Why Choose Suddath to "Move" your Career to the Next Level?

At Suddath, you can be part of something special and inclusive! Join a team that has a 100+ year reputation for excellence as an innovative, growing and financially stable company that is dedicated to promoting a culture that thrives on inclusion and diversity. From numerous awards to being recognized as one of the best places to work, Suddath offers a caring, family environment while providing relocation and logistics services to people and companies all around the world.

What We Offer!

• A competitive wage with a comprehensive benefits package, including a 401(k) plan with company matching
• Weekly pay for hourly-paid employees. Biweekly pay for salaried employees.
• Paid Time Off (PTO) and paid company holidays
• A tuition reimbursement plan where employees are encouraged to continue their education and development

For more information on our benefit offerings, please visit https://suddath.com/about/careers/ and scroll down to view our employee benefits.

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 co