Manager, Tool and Test Equipment - Service
Johnson & Johnson
June 26, 2026
Remote friendly (Santa Clara, CA)
United States
Operations
Position: Manager, Tool and Test Equipment (Santa Clara, CA)
Responsibilities:
- Lead risk-based selection and justification of measurement and test equipment.
- Review technical documentation/regulatory requirements for precision, tolerances, and traceability.
- Maintain a master equipment register and SOPs for tool selection/qualification.
- Develop and manage supplier evaluation/qualification programs; audit OEMs/calibration houses/distributors.
- Oversee contracts, service-level agreements, performance scorecards, and corrective actions.
- Create risk-based calibration schedules; use digital calibration/CMMS systems for tracking/records.
- Conduct Out-of-Tolerance (OOT) quarantine/impact assessment; lead root-cause and CAPA; ensure audit-ready documentation.
- Forecast obsolescence; manage retirement, traceability controls, and decommissioning documentation.
- Drive continuous improvement using analytics (OOT trends, MTBF, predictive maintenance, CpK, service metrics).
- Develop/enforce equipment control SOPs; serve as audit liaison; maintain regulatory surveillance.
Required Qualifications:
- Extensive experience managing test equipment and calibration programs in regulated medical device environments.
- Project management for multi-phase initiatives; on-time/on-scope delivery.
- Experience supporting regulatory inspections and audit walkthroughs.
- Strong metrology knowledge (tolerances, uncertainty, traceability).
- Proficiency with electronic calibration tools (e.g., SimplerQMS, Blue Mountain, MasterControl).
- Advanced Power BI/data analysis; strong SOP documentation and cross-functional communication.
Preferred Qualifications:
- Medical device service process knowledge; experience specifying/qualifying/validating measurement tools.
- Familiarity with IEC 62353, IEC 60601, ISO 14971; statistical process control and risk-based decision-making.
- ERP integration and digital document control experience.
Compensation/Benefits (as stated): Salary range $118,000–$203,550 (Bay Area). Eligible for company medical/dental/vision and other listed benefit programs and time-off per plans.
Responsibilities:
- Lead risk-based selection and justification of measurement and test equipment.
- Review technical documentation/regulatory requirements for precision, tolerances, and traceability.
- Maintain a master equipment register and SOPs for tool selection/qualification.
- Develop and manage supplier evaluation/qualification programs; audit OEMs/calibration houses/distributors.
- Oversee contracts, service-level agreements, performance scorecards, and corrective actions.
- Create risk-based calibration schedules; use digital calibration/CMMS systems for tracking/records.
- Conduct Out-of-Tolerance (OOT) quarantine/impact assessment; lead root-cause and CAPA; ensure audit-ready documentation.
- Forecast obsolescence; manage retirement, traceability controls, and decommissioning documentation.
- Drive continuous improvement using analytics (OOT trends, MTBF, predictive maintenance, CpK, service metrics).
- Develop/enforce equipment control SOPs; serve as audit liaison; maintain regulatory surveillance.
Required Qualifications:
- Extensive experience managing test equipment and calibration programs in regulated medical device environments.
- Project management for multi-phase initiatives; on-time/on-scope delivery.
- Experience supporting regulatory inspections and audit walkthroughs.
- Strong metrology knowledge (tolerances, uncertainty, traceability).
- Proficiency with electronic calibration tools (e.g., SimplerQMS, Blue Mountain, MasterControl).
- Advanced Power BI/data analysis; strong SOP documentation and cross-functional communication.
Preferred Qualifications:
- Medical device service process knowledge; experience specifying/qualifying/validating measurement tools.
- Familiarity with IEC 62353, IEC 60601, ISO 14971; statistical process control and risk-based decision-making.
- ERP integration and digital document control experience.
Compensation/Benefits (as stated): Salary range $118,000–$203,550 (Bay Area). Eligible for company medical/dental/vision and other listed benefit programs and time-off per plans.