Job Details

Quality Assurance SpecialistLocation:Greenville, NCPay Rate:$27.00 per hourSchedule:6:00 PM – 6:00 AM | 12-hour shifts | 2-2-3 rotationWork Setting:Fully On-SiteInterview:In-PersonEmployment Type:Full-TimePosition SummaryWe are seeking an experiencedQuality Assurance Specialistto 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 inQuality Assurance, Quality Control, engineering, operations, or manufacturing, preferably within a highly regulated environment such as medical devices, pharmaceuticals, or other regulated manufacturing industries.Key ResponsibilitiesPerform 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.QualificationsBachelor's degree, preferably inEngineering, Life Sciences, Technology, Quality, Microbiology, or a related technical fieldEquivalent combinations of education, training, and relevant work experience may be considered.Minimum of4 years of relevant experiencein Quality Assurance, Quality Control, Engineering, Operations, or Manufacturing.Previous experience in themedical device industry or another highly regulated manufacturing environmentis strongly preferred.Experience working within anISO 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 asCertified Quality Auditor (CQA)and training inSix Sigmaare a plus.Schedule6:00 PM – 6:00 AM12-hour shifts2-2-3 rotating schedule40-minute paid lunchSchedule may include weekends and holidays based on business and production needs.Training may be provided on an alternate schedule as needed.Physical RequirementsThis 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 approximately10–35 poundsPerform 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 PPEEmployees may be required to wear:Safety glassesSafety shoesLab coatNitrile or similar protective glovesSafety apronOrganic respirator when requiredWork EnvironmentThis is afully on-site positionin 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 ProcessIn-person interviewCompensation$27.00 per hourPay Details: $27.00 per hourBenefit 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/DisabledMilitary connected talent encouraged to applyTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate toThe 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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance OrdinanceMassachusetts 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.