Quality Assurance Manager
Direct Hire position!
- Maintain effectiveness of Quality Management System and compliance with ISO/FDA regulations
- Ensure the effectiveness of quality control acceptance and release activities
- Manage sterilization program, test labs and supplier quality
- Manage drug/pharma quality control and analytical test activities
- Manage bioburden and environmental monitoring and data analysis activities
- Maintain quality performance metrics and oversee improvement activities
- Support sales with customer quotes for products and services
- Lead supplier qualifications and monitor ongoing performance
- Lead corrective -action, nonconformance and complaint investigations
- Review/approve document changes, equipment and process qualification and validation protocols/reports
- Assist with tasks as needed/ requested by supervisor
- Bachelor's degree in Engineering or Science discipline is required.
- Certified Quality Engineer (CQE) or equivalent RA/QA certification in the area of regulated healthcare products is preferred.
- Statistical Process Control (SPC) and Lean Six Sigma training is preferred.
- 5-7 years managing quality assurance working in a medical
- FDA (CFR 820, 210 and 211), and ISO 13485 quality management systems experience is required.
- Process Failure Modes and Experience with the application of ISO 14971 for process FMEA and process validations (IQ/OQ/PQ) to mitigate risks is preferred.
- Data analysis and writing technical reports using Microsoft Office and analytical software such as Minitab is preferred.