CAPA Engineer

• 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.