Overview
Manufacturing Quality Specialist – Medical Devices Jobs in Greenville, NC at Infotree Global Solutions
Position Summary
We are seeking a Quality Assurance Specialist with hands-on experience supporting manufacturing/assembly operations in the medical device industry. This role will provide quality oversight on the production floor and support QMS compliance, documentation, investigations, and continuous improvement activities.
Strong medical device quality experience is highly preferred.
Shift Options
- 1st Shift: 6:00 AM – 6:00 PM | 2-2-3 rotating schedule
- 2nd Shift: 6:00 PM – 6:00 AM | 2-2-3 rotating schedule
Key Responsibilities
- Provide daily quality support and oversight for medical device manufacturing and assembly operations.
- Ensure compliance with QMS, ISO 13485, MDR, SOPs, and applicable medical device regulations.
- Review DHRs (Device History Records), manufacturing documentation, and batch/production records.
- Support and investigate nonconformances, deviations, CAPAs, complaints, and other quality events.
- Participate in root cause analysis and implement corrective/preventive actions.
- Work directly with Manufacturing, Operations, Engineering, and Quality teams to resolve production and quality issues.
- Support documentation corrections, process improvements, and continuous improvement initiatives.
- Promote a strong quality and compliance culture on the manufacturing floor.
Qualifications
- 4+ years of experience in Quality Assurance, Quality Control, Manufacturing, Operations, or a related function.
- Hands-on experience in medical device manufacturing/assembly strongly preferred.
- Strong experience with DHR, QMS, ISO 13485, nonconformance, CAPA, and medical device quality processes.
- Experience working directly on or supporting a manufacturing/assembly production line.
- Knowledge of MDR and applicable medical device regulatory requirements.
- Strong troubleshooting, documentation, communication, and problem-solving skills.
- CQA, Six Sigma, or related certification is a plus.
- Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field preferred; equivalent experience may be considered.
Pay: $15.00 – $27.00 per hour
Expected hours: 40.0 per week
Work Location: In person
Title: Manufacturing Quality Specialist – Medical Devices
Company: Infotree Global Solutions
Location: Greenville, NC
Category:
