Senior CAPA & Quality Improvement Specialist

Stryker; Mahwah (NJ); On-site; USD 87,000 - 145,000; Full time

Job summary

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supporting the Joint Replacement portfolio in Mahwah, NJ. Working within the QMS to ensure CAPA compliance and reviewing NCs and CAPAs for completeness, accuracy, effectiveness and timeliness.

This role applies CAPA, root cause analysis, and problem-solving methodologies to drive corrective actions, maintain CAPA documentation in TrackWise, facilitate CAPA review meetings, monitor metrics, and support audits and

Qualifications

• Demonstrated experience managing Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, including root cause investigations, implementation of corrective actions, effectiveness verification, and continuous quality improvement initiatives.

Responsibilities

• Facilitate NC & CAPA teams in problem-solving techniques.
• Partner with cross-functional teams to drive investigations and resolutions.
• Maintain CAPA documentation and records in QMS (e.g., TrackWise).
• Facilitate CAPA review meetings and contribute to quality discussions.
• Monitor CAPA metrics and support quality reviews and audits.

Skills

CAPA management

Root cause analysis

Problem solving

Education

Bachelor’s degree or higher in science/engineering

Job description

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supporting the Joint Replacement portfolio in Mahwah, NJ. Working within the QMS to ensure CAPA compliance and reviewing NCs and CAPAs for completeness, accuracy, effectiveness and timeliness.

This role applies CAPA, root cause analysis, and problem-solving methodologies to drive corrective actions, maintain CAPA documentation in TrackWise, facilitate CAPA review meetings, monitor metrics, and support audits and