Job Details

Quality Assurance SpecialistIn this position, you will drive quality execution across medical device operations, including manufacturing, assembly, inspection, testing, packaging, and associated non-production-order-specific activities for commercial and product development products. Additionally, this position will provide quality guidance and expertise for implementing practical process improvements and continuous improvement initiatives. Typical hours are from 6 PM to 6 AM, on a 2-2-3 rotation.ResponsibilitiesPerform daily quality assessments of facility, personnel, manufacturing activities, and documentation to uncover errors or deficiencies and assure quality and compliance with site procedures, the Quality Management System (QMS), cGMPs, and applicable medical device regulatory requirements.Interact daily with employees to assist with troubleshooting, documentation corrections/notes, and guidance on controlled manufacturing practices, contamination control, and adherence to approved work instructions.Champion a quality culture by helping personnel understand and apply QMS procedures, quality policies, process controls, and applicable regulatory requirements.Participate in quality event response (RAPID) and provide quality guidance for nonconformances, deviations, and other manufacturing quality events.Escalate nonconformance and deviation events to the appropriate functional and Quality management teams.Perform quality review and approval of procedures, work instructions, training documents, specifications, and forms of moderate to high complexity.Perform quality review and approval of nonconformances, deviations, CAPAs, and change controls of moderate to high complexity.Participate as the Quality Assurance representative in root cause analysis and investigations for nonconformances, deviations, complaints, and other quality events of moderate to high complexity, as applicable.Perform quality batch record review.Aid in identifying continuous improvement opportunities and participate in practical process and quality system improvement initiatives.Essential SkillsBachelor's degree, preferably in engineering, life sciences, technology, quality, or a related technical field.Minimum of 4 years of experience in Quality Assurance, Quality Control, Engineering, or Operations/Manufacturing.Previous experience in the medical device industry or another highly regulated manufacturing environment.Experience working within an ISO-compliant quality management system and familiarity with applicable medical device regulatory requirements.Ability to capture and analyze data and troubleshoot process, inspection/test, documentation, and equipment issues.Hard-working, demonstrated ownership & responsibility.Ability to lead, support, and empower a team/peers.Additional Skills & QualificationsProfessional certifications (e.g., CQA) and training (Six Sigma) are a plus.Equivalent combinations of education, training, and relevant work experience may be considered.Work EnvironmentThe primary responsibilities require consistent production floor presence, which necessitates physical fitness for prolonged standing, walking, and repetitive bending. It also involves using required personal protective equipment and gowning appropriate to controlled manufacturing areas.Job Type & LocationThis is a Contract position based out of Greenville, NC.Pay and BenefitsThe pay range for this position is $15.00 - $27.00/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)Workplace TypeThis is a fully onsite position in Greenville, NC.Application DeadlineThis position is anticipated to close on Sep 18, 2026.