Senior CAPA Specialist
Stryker · Mahwah, NJ
QualityFull-time$87k–$145kCompany career page
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Role summary
Senior CAPA Specialist position within the Joint Replacement division's quality management system. The role focuses on managing nonconformance and corrective/preventive action processes, applying problem-solving methodologies, and ensuring compliance with regulated industry standards.
What they're looking for
- Bachelor's degree in science, engineering, or related technical field
- 2+ years experience in medical device or pharmaceutical regulated environments
- Demonstrated experience managing NC and CAPA processes including root cause analysis
- Knowledge of problem-solving methodologies and continuous quality improvement
- Experience with regulatory agencies (FDA, MoH, TUV) preferred
- Familiarity with FDA and international medical device quality system standards preferred
What you'll be doing
- Review and approve nonconformance and CAPA documentation for completeness and accuracy
- Facilitate and coach cross-functional teams in problem-solving techniques and methodologies
- Conduct root cause analysis and drive timely resolution of quality issues
- Maintain accurate CAPA documentation in electronic quality management systems
- Monitor CAPA metrics, prepare reports, and support quality business reviews
Privacy & handoff
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