Engineer

• Responsible for managing, leading, and completing Product and Cloud Software CAPA phases effectively and on time from issue identification to resolution and verification of effectiveness.
• Partner with Product Software, Cloud Software, Product Owners, and Software Quality Assurance teams to ensure CAPA deadlines are met.
• Work with CAPA Process Owner to ensure Product and Cloud Software CAPAs are managed efficiently and effectively.
• Mentor other CAPA owners on the execution of CAPAs
• May be responsible for planning and tracking CAPA performance against key performance indicators (KPIs)
• Assist in the development, implementation and maintenance of the quality system and its procedures
• In conjunction with the Quality Systems Director, maintain QMS compliance with Medical Device Single Audit Program and ISO 13485
• Suggest methods for and improve quality system effectiveness, with emphasis on preventive action

Staff Product Performance Engineer

Engineer I

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