What are the responsibilities and job description for the Process Improvement Engineer position at Bolt Medical?
Bolt Medical seeks a Quality Assurance Manager to provide quality engineering support and leadership for Manufacturing Process development and implementation.
This position will work closely with Manufacturing in the manufacture of disposable medical catheters in compliance with applicable regulatory and statutory requirements.
Key duties include:
- Overseeing EO sterilization validation processes and ensuring routine sterilization activities meet regulatory standards.
- Supporting environmental monitoring and clean room verifications according to schedule and assisting with excursion investigations.
- Reviewing and approving manufacturing validation test plans, protocols, and test reports.
- Leading the completion of risk management deliverables, including process FMEA and Control Plans.
- Supporting and leading test method validation activities to ensure accurate and reliable testing processes.
Experience in catheter design and production, or with similar medical devices, while working within Quality is required.
