Quality Engineer at Katalyst Healthcares Life Sciences
Murrysville, PA 15668, USA -
Full Time


Start Date

Immediate

Expiry Date

30 Apr, 25

Salary

0.0

Posted On

31 Jan, 25

Experience

7 year(s) or above

Remote Job

No

Telecommute

No

Sponsor Visa

No

Skills

Remediation

Industry

Pharmaceuticals

Description

Responsibilities:

  • 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.

Requirements:

  • 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:

Responsibilities
  • 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
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