Overview
Quality Engineer Jobs in Murrysville, PA at Invent Staffing
Title: Quality Engineer
Company: Invent Staffing
Location: Murrysville, PA
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
