We are looking for ??System Quality Assurance Engineer for our client in Morrisville, NC
Job Title: ??System Quality Assurance Engineer
Job Location: Morrisville, NC
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
- Actively contribute to Change Review Board as part of change control process.
- Ensure compliance to regulatory requirements.
- Uphold quality system.
- Support internal and external audits.
- Work in a cross-functional team environment including members from Manufacturing, Clinical, Regulatory, and Marketing.
- Serve as quality representative for New Product Development.
- Contribute to requirements definitions and ensure that reliability, quality, and safety requirements are met.
- Work closely with Engineering to develop test protocols and reports
- Develop, implement, and monitor various quality metrics.
- Identify opportunities for continuous improvement and customer satisfaction.
- Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
- Gather and analyze data for root cause analysis.
- Coordinate and drive efforts to assure CAPAs are opened and completed appropriately.
- Work with Engineering and Manufacturing to develop and implement corrective actions.
- Support complaint sample evaluations and investigations.
- Track complaint data to identify actionable trends.
- Respond to customer and regulatory inquiries.
- Perform risk assessments and analysis.
- Participate in risk management meetings.