Quality Complaints & Operations Lead

Quality Complaints & Operations Lead

Medical Device Quality | Complaint Handling | Frontline Team Leadership

Position Overview

This is a hands-on leadership opportunity for a medical device quality professional who wants to combine complaint-handling expertise with day-to-day team oversight. The Quality Complaints & Operations Lead supports the complaint process from intake through closure while supervising personnel involved in kitting, assembly, repackaging, relabeling, and quality support activities. The role connects customer and field feedback with the operational teams responsible for product handling, documentation, labeling, and corrective action.

You will remain close to the work: leading investigations, supporting regulatory reporting, coaching team members, assigning daily priorities, reviewing records, and helping ensure that quality requirements are met without losing sight of operational needs.

Location & Schedule

• HQ - Morrisville, NC
• Work is performed across office and active production/warehouse environments.
• Occasional travel may be required for customer, supplier, or OEM visits; final travel expectations will be confirmed.

What You Will Do

• Support and coordinate the medical device complaint-handling process, including intake, triage, investigation, disposition, documentation, and closure.
• Evaluate and document medical device reportability decisions and prepare or submit MDRs through eMDR within applicable regulatory timelines under 21 CFR Part 803.
• Evaluate and document corrections and removals under 21 CFR Part 806 when required.
• Lead root-cause investigations and escalate complaint severity or trend signals that may warrant corrective and preventive action (CAPA).
• Maintain complete, accurate, retrievable, and audit-ready complaint files and quality records.
• Analyze complaint data and communicate trends, metrics, risks, and follow-up actions to Quality and Operations leadership.
• Supervise day-to-day work for assigned kitting, assembly, quality, or complaint-support personnel, including scheduling, task assignment, coverage, coaching, cross-training, and work prioritization.
• Provide hiring input, performance feedback, training, and development support for assigned team members.
• Support labeling and packaging controls, including label accountability, reconciliation, and documented line clearance.
• Review batch or device history records and support product-release decisions against defined acceptance criteria.
• Support lot traceability and the identification, segregation, documentation, and disposition of nonconforming product and rework.
• Partner with planning, customer service, Quality, and Operations to balance delivery requirements with quality and regulatory expectations.
• Support internal and external audits and FDA inspections, including record retrieval, process explanation, response support, and closure of findings within the roles scope.
• Deliver and document training for complaint-handling, quality, and operations personnel.
• Promote a work environment where quality concerns are raised promptly and product or work is held when established requirements are not met.

Top Qualifications

• 3+ years of relevant experience in medical device quality, complaint handling, product surveillance, quality investigations, or a closely related regulated medical device function.
• Hands-on experience investigating medical device complaints and maintaining complaint records.
• Experience supporting or performing MDR/eMDR activities under 21 CFR Part 803.
• Experience leading, supervising, or coordinating the daily work of employees in quality, production, kitting, assembly, packaging, or a related regulated operation.
• Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016.
• Experience with root-cause investigation, CAPA, nonconforming product, and quality documentation.
• Experience supporting FDA inspections and/or external quality audits.

Required Qualifications

• Bachelor's degree in a life science, engineering, or related field, or an equivalent combination of education and relevant experience.
• 3+ years of relevant medical device quality experience, including complaint handling or complaint investigation.
• Hands-on experience with MDR reportability assessment, MDR documentation, or eMDR preparation/submission under 21 CFR Part 803.
• Demonstrated ability to conduct structured investigations and document conclusions under regulatory timelines.
• Demonstrated experience assigning work, coaching employees, coordinating coverage, or supervising day-to-day team activities.
• Working knowledge of ISO 13485:2016 and medical device quality-system requirements.
• Ability to work on-site across office and production/warehouse environments.
• Ability to maintain detailed, accurate, and audit-ready quality records.

Preferred Qualifications

• Experience in medical device kitting, assembly, repackaging, relabeling, contract manufacturing, or third-party logistics operations.
• Experience with labeling controls, line clearance, lot traceability, device or batch history records, product release, or nonconforming-product control.
• Familiarity with corrections and removals under 21 CFR Part 806 and recall execution.
• Experience with electronic quality management, warehouse management, ERP, or label-control systems.
• UDI/GUDID experience under 21 CFR Part 830.
• ASQ certification such as CQA, CQE, or CMQ/OE.
• ISO 13485 or MDSAP auditor training.
• Experience with device-plus-drug kits or combination products under 21 CFR Part 4.

Core Competencies

• Complaint investigation and regulatory documentation.
• Frontline supervision, coaching, and daily work coordination.
• Root-cause analysis and structured problem-solving.
• Clear decision-making and escalation under regulatory and operational deadlines.
• Written and verbal communication with Quality, Operations, customers, OEMs, and auditors.
• Quality metrics, trend analysis, and documentation discipline.

Physical Demands & Work Environment

• Regular work in both office and production/warehouse environments.
• Prolonged standing and walking and frequent movement across the operation.
• Controlled-environment, GMP housekeeping, and PPE requirements may apply.
• The final lifting requirement will be confirmed before an offer is extended.

Job Type & Location

This is a Contract to Hire position based out of Morrisville, NC.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of Morrisville, NC.

Application Deadline

This position is anticipated to close on Oct 23, 2026.

Workplace Type

This is a hybrid position in Morrisville,NC.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.