The Quality Assurance Specialist is responsible for coordinating designated quality initiatives to ensure compliance with FDA Current Good Manufacturing Practices, ISO 13485:206, and European Standards. This position supports the Quality Management System through maintenance of document control and the facilitation of investigation and closing of complaints, corrective and preventative action reports, supplier corrective action reports and product non-conformance reports. This individual performs incoming or production product inspections when needed and participates in audits of the facility conducted by notified bodies, the FDA, internal initiatives, and customers.
- Facilitates the investigation and closing of complaints.
- Facilitates and closes internal and supplier corrective action reports.
- Works with internal audit team to schedule and execute audits according to an approved audit schedule, reporting findings and ensuring corrective actions are appropriate and implemented.
- Distributes audit reports to management.
- Initiates nonconforming product processes.
- Assists in the management of recall and field correction activities by ensuring timelines are met and activities are properly documented.
- Maintains document control within the Quality Management System.
- Performs incoming and production product inspection, recording and uploading inspection results.
- Other related tasks as assigned.
Education, Training, Licensure/Certification
- Associate Degree
- 2 – 5 years of related experience including Quality Assurance and/or Quality Control
- Prior experience working in the Medical Device field or highly regulated industry, desired
- Internal Auditor Training, preferred
Knowledge, Skills, and Abilities
- Basic math skills
- Knowledge of Excel and basic Microsoft Office is required
- Professional writing skills and professional demeanor required
- Must be organized and detail oriented
- Knowledge of root cause analysis and problem solving methods, preferred