System Quality Assurance Engineer
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.
- Supportinternal 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 withEngineering 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.
Educational qualification (if must):
- B.S degree in Science or Engineering (CQE certification is preferable)
- 3 + years experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry; quality engineering or product development experiencepreferred; experience with Post Market Surveillance a plus.
- Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods
- Knowledge of quality control process and statistical techniques.
- Strong analytical and problem solving skills; strong attention to detail.
- Understanding of manufacturing processes and techniques.
- Working knowledge of lean manufacturing, Six Sigma, Project Management principles a plus.
- Proficient with Excel (PivotTables, trending, charting).
- Excellent verbal and written communication skills, including the ability to influence others.
- Strong interpersonal skills and the ability to work with cross-functional teams.
- Project management skills
- High level of initiative with ability to self-manage