Quality Assurance Specialist

Job Description

Job Description

Quality Assurance Specialist

Location: Greenville, NC
Pay Rate: $27.00 per hour
Schedule: 6:00 PM – 6:00 AM | 12-hour shifts | 2-2-3 rotation
Work Setting: Fully On-Site
Interview: In-Person
Employment Type: Full-Time

Position Summary

We are seeking an experienced Quality Assurance Specialist to support quality execution across medical device manufacturing operations, including manufacturing, assembly, inspection, testing, packaging, and related production activities.

This position will serve as a quality resource on the production floor, providing guidance to manufacturing personnel, supporting quality investigations, ensuring compliance with established procedures and regulatory requirements, and identifying opportunities for practical process and continuous improvement.

The ideal candidate will have experience in Quality Assurance, Quality Control, engineering, operations, or manufacturing , preferably within a highly regulated environment such as medical devices, pharmaceuticals, or other regulated manufacturing industries.

Key Responsibilities

• Perform daily quality assessments of facilities, personnel, manufacturing activities, and documentation to identify errors, deficiencies, and potential compliance concerns.

• Ensure manufacturing activities comply with site procedures, the Quality Management System (QMS), cGMPs, and applicable medical device regulatory requirements.

• Maintain a consistent presence on the production floor to provide quality oversight and support.

• Work directly with employees to assist with troubleshooting, documentation corrections, and proper adherence to controlled manufacturing practices.

• Provide guidance on contamination control, process controls, and approved work instructions.

• Champion a strong quality culture by helping employees understand and apply QMS procedures, quality policies, process controls, and applicable regulatory requirements.

• Participate in quality event response activities and provide quality guidance during nonconformances, deviations, and other manufacturing quality events.

• Escalate nonconformance and deviation events to appropriate functional and Quality management teams.

• Review and approve procedures, work instructions, training documents, specifications, and forms of moderate to high complexity.

• Review and approve nonconformances, deviations, CAPAs, and change controls of moderate to high complexity.

• Participate as a Quality Assurance representative in root cause analysis and investigations involving nonconformances, deviations, complaints, and other quality events.

• Perform quality review of batch production records and associated documentation.

• Capture and analyze quality data to identify trends, issues, and opportunities for improvement.

• Partner with production and technical leadership to troubleshoot process, inspection, testing, documentation, and equipment issues.

• Identify continuous improvement opportunities and participate in practical process and quality-system improvement initiatives.

• Promote accountability, ownership, and adherence to quality standards throughout manufacturing operations.

Qualifications

• Bachelor's degree, preferably in Engineering, Life Sciences, Technology, Quality, Microbiology, or a related technical field .

• Equivalent combinations of education, training, and relevant work experience may be considered.

• Minimum of 4 years of relevant experience in Quality Assurance, Quality Control, Engineering, Operations, or Manufacturing.

• Previous experience in the medical device industry or another highly regulated manufacturing environment is strongly preferred.

• Experience working within an ISO 13485-compliant Quality Management System (QMS) is preferred.

• Familiarity with applicable medical device regulatory requirements is preferred.

• Experience in other regulated manufacturing environments may be considered.

• Strong ability to capture, analyze, and interpret data.

• Strong troubleshooting and problem-solving skills.

• Ability to identify and resolve process, inspection, testing, documentation, and equipment issues.

• Strong written and verbal communication skills.

• Demonstrated ownership, accountability, and attention to detail.

• Ability to lead, support, coach, and empower peers and production personnel.

• Ability to work effectively both independently and as part of a cross-functional team.

• Professional certifications such as Certified Quality Auditor (CQA) and training in Six Sigma are a plus.

Schedule

• 6:00 PM – 6:00 AM

• 12-hour shifts

• 2-2-3 rotating schedule

• 40-minute paid lunch

• Schedule may include weekends and holidays based on business and production needs.

• Training may be provided on an alternate schedule as needed.

Physical Requirements

This position requires consistent production-floor presence and the ability to:

• Stand and walk for extended periods.

• Periodically stoop, kneel, crouch, bend, and reach.

• Lift, carry, and move materials weighing approximately 10–35 pounds .

• Perform repetitive arm, hand, and finger movements.

• Grasp and type for prolonged periods.

• Use computers, monitors, production equipment, and other systems.

• Read documentation and other materials for extended periods.

• Communicate effectively with team members and production personnel.

• Perform required gowning and follow controlled manufacturing-area procedures.

• Maintain the physical ability necessary to safely perform assigned duties.

Required PPE

Employees may be required to wear:

• Safety glasses

• Safety shoes

• Lab coat

• Nitrile or similar protective gloves

• Safety apron

• Organic respirator when required

Work Environment

This is a fully on-site position in a regulated manufacturing environment. The Quality Assurance Specialist will maintain a consistent presence on the production floor and work closely with manufacturing, technical, and Quality teams.

The successful candidate must be comfortable working in a fast-paced manufacturing environment while following established quality, safety, documentation, and regulatory requirements.

Interview Process

In-person interview

Compensation

$27.00 per hour

Pay Details: $27.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to -us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: 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.