CAPA Quality Engineer – Med Device, Root Cause & PM

Katalyst CRO; Murrysville (Westmoreland County); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in the United States seeks a senior CAPA Engineer to lead corrective and preventive actions across product and process improvements within a regulated medical device environment.

You will drive complex CAPA investigations, mentor cross-functional teams, manage projects end-to-end, and ensure compliance with 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.

Qualifications

• CAPA investigations from issue identification through solution and effectiveness monitoring.
• Project manage CAPA activities with cross-functional resources and timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross functional teams with root cause analysis techniques.
• Analyze quality monitoring data and apply statistical methods to identify causes of non-conformances.
• Collaborate with management to ensure CAPA plans have required resources and cost support.
• Independently produce CAPA records and complete CAPA tasks.

Responsibilities

• Facilitate CAPA investigations from issue identification through implementation and monitoring.
• Project manage CAPA activities with cross-functional teams and timelines.
• Represent CAPA activities during audits and CAPA Review Board meetings.
• Lead and mentor teams in root cause analysis techniques.
• Analyze quality data to identify and address non-conformances.
• Ensure management supports CAPA action plans with needed resources.

Skills

CAPA leadership

Root cause analysis

Statistical methods

Project management

Cross-functional teamwork

Education

Bachelor's in Engineering

Master's in Engineering

Job description

Katalyst CRO in the United States seeks a senior CAPA Engineer to lead corrective and preventive actions across product and process improvements within a regulated medical device environment.

You will drive complex CAPA investigations, mentor cross-functional teams, manage projects end-to-end, and ensure compliance with 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.