A-Line Staffing is now hiring
Medical Device Quality Engineer in
Sumter, SC 29153. The
Medical Device Quality Engineer would be working for a Major Medical Device Manufacturer and has career growth potential.
Medical Device Quality Engineer Highlights:
- Schedule: Full-time, onsite (PPE required on production floor)
- Pay Range: $37.04 Hourly
- Duration: 7-month contract (potential to extend/convert)
Medical Device Quality Engineer Responsibilities:
- Support product and service quality evaluation and control within the Specimen Acquisition Group (blood collection products)
- Work cross-functionally with manufacturing, process engineers, and quality teams
- Investigate production and equipment-related issues and support root cause analysis (Fishbone Diagram, etc.)
- Perform complaint support and remediation activities, including:
- – Reviewing complaint database and identifying manufacturing origin– Ensuring accurate coding and documentation of complaints– Coordinating with production and engineering teams to investigate defects– Driving corrective actions and remediation efforts
- Analyze nonconformities and identify trends alongside quality engineering teams
- Utilize systems such as TrackWise (training provided) and SAP for documentation
- Write test protocols, execute testing, collect/analyze data, and generate validation reports
- Apply statistical analysis and metrics to evaluate processes and systems
- Support validation activities for equipment, processes, materials, and methods
- Ensure compliance with regulatory requirements (cGMP, FDA, ISO)
Medical Device Quality Engineer Qualifications:
- Bachelor’s Degree required (preferably in Engineering or related field)
- 6 months to 2.5 years of experience in a highly regulated environment (cGMP, FDA, ISO)
- Strong experience with Microsoft Excel (macros preferred)
- Experience with TrackWise (or willingness to learn); SAP and Minitab preferred
- Knowledge of root cause analysis tools (Fishbone Diagram, etc.)
- Strong data analysis and statistical skills
- Excellent communication and collaboration skills
- Ability to work onsite and follow PPE requirements
If you are interested in this
Medical Device Quality Engineer position, please apply to this posting with Luke H. at A-Line!