Quality Control​/Quality Assurance Specialist

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

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.

• 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 nonconformance, 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.

• 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.

• 6:00 PM - 6:00 AM

• 12-hour shifts

• 2-2-3 rotating schedule

• 40-minute paid lunch

• Schedule may include…