What are the responsibilities and job description for the Quality Engineer position at Invent Staffing?
Position: Quality Engineer
Location: Murrysville PA
Duration: 12 Month Contract With Possible Extension
Description:
Hands on experience in Medical devices product engineering, manufacturing, Gap assessment, Remediation, Risk Management, Verification and Validation of Medical devices.
Skills Matrix:
Remediation, CAPA, Non-conformances, Product Holds, DHRs, Risk management, Change control Management, Technical writing – reports and technical justification, 21 CFR 820, ISO 13485, ISO 14971
No. of years of experience: 7 years in medical devices
Job Description:
To perform assess, review and perform remediation activities
- Prioritize timely completion and remediation of Corrective Action and Preventive Action (CAPA) – performing investigations, corrections, corrective actions, preventive actions and effectiveness checks.
- Perform review and remediation of Nonconforming Records and Product Holds
- Maintain, monitor and report trend analysis information on assigned products.
- Develop and maintain a robust process for identifying and monitoring root cause failure modes, frequency, and severity.
- Maintain and remediation process failure mode effects analysis (pFMEAs) for the products.
- Support returned product analysis and failure investigation activities for manufactured products (explant lab).
- Conduct all engineering activities in compliance with FDA's Quality System Regulation, Medical Device Directive (MDD), ISO 13485, Canadian CMDR, and other quality and regulatory requirements and standards.
- Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
Minimum Qualifications:
- Engineering degree or BS/MS (i.e. mechanical, electro-mechanical, electrical, etc.) or equivalent experience
- 7 years of experience in medical device quality, preferably in remediation
- Working knowledge of FDA QSRs, 13485 and 14971
- Ability to manage multiple stakeholders and competing priorities.
Key required experience:
- FDA CFR 820
- ISO 13485
- Supply chain/factory experience
- NCM
- Receiving Inspection
- Product holds
- CAPA/root cause analysis
