CAPA Engineer

Katalyst-Healthcares-; Utah; On-site; USD 100,000 - 150,000; Full time

Job summary

Katalyst-Healthcares- seeks a CAPA Manager to lead investigations, implement corrective actions, and monitor effectiveness in a regulated manufacturing setting in Utah.

You will oversee day-to-day CAPAs, own strategic CAPAs, mentor CAPA staff, and support quality system updates, audits, and continuous improvement.

Qualifications

• CAPA management and investigations from initiation through closure.
• Experience in controlled manufacturing environments, including lab and manufacturing operations.
• Assess product impact, develop corrective actions, implement them, and monitor effectiveness.
• Ability to manage multiple CAPAs, drive collaboration, and learn processes quickly.
• Experience with PLM, MES, ERP systems or related tools.
• Familiarity with nonconformance, CAPA, audits, complaints and environmental monitoring systems.

Responsibilities

• Manage day-to-day CAPAs, including investigations, corrections, action implementation, monitoring, and closure.
• Take ownership of individual CAPAs and help accelerate the CAPA process.
• Oversee about 2–3 strategic CAPAs; lead may manage 6–7 CAPAs while coordinating others.
• Support quality system updates and ensure documentation compliance.
• Provide guidance and coaching to CAPA personnel for the lead-level position.
• Support the CAPA Chair for the lead-level position.
• Address approximately 80–90 standalone CAPAs and internal audit-related CAPAs.

Skills

CAPA management

Investigations

Controlled manufacturing environments

Product impact assessment

Corrective actions implementation

Cross-functional collaboration

Learning processes quickly

Tools

PLM systems

MES

ERP

LIMS

Environmental monitoring systems

Job description

Job Description:

• Manage CAPAs day to day, including investigations, corrections, action implementation, monitoring, and closure.
• Take ownership of individual CAPAs and help accelerate the overall CAPA process.
• Manage approximately 2–3 strategic CAPAs; a seasoned lead may manage 6–7 CAPAs while coordinating others conducting investigations.
• Support quality system updates and modifications and ensure documentation compliance.
• Provide guidance and coaching to additional CAPA personnel for the lead-level position.
• Support the CAPA Chair for the lead-level position.
• Work may include addressing approximately 80–90 standalone CAPAs and internal audit-related CAPAs.

Important Skills Needed:

• CAPA management and processing experience, including leading investigations from initiation through closure.
• Experience in controlled manufacturing environments, including laboratory and manufacturing operations.
• Ability to assess product impact, develop corrective actions, implement them, and monitor effectiveness.
• Ability to manage multiple CAPAs, drive collaboration, and learn processes quickly.
• Experience with PLM systems.
• Familiarity with MES, ERP, nonconformance, CAPA, audit, complaint, LIMS, maintenance, or environmental monitoring systems is relevant.
• Strong communication, ownership, organization, and emotional intelligence.