Sr. Engineer, R&D CAPA
仕事内容
Lead design controls and CAPA investigations within the R&D organization, from problem definition through implementation.
Perform thorough root cause analyses using tools such as Fishbone, 5 Whys, and FMEA; develop risk-based CAPAs.
Create robust corrective and preventive actions with clear timelines, acceptance criteria, and effectiveness verification plans.
Ensure CAPA documentation and traceability meet FDA, ISO 13485, and internal QMS requirements; collaborate cross-functionally with Quality, Regulatory Affairs, Operations, and Manufacturing Engineering.
Provide technical guidance and mentorship to R&D engineers; support audits with CAPA rationale and technical explanations.
Identify opportunities to improve CAPA execution and contribute to broader quality system and R&D process improvements; operate with autonomy as a technical CAPA authority.
Perform thorough root cause analyses using tools such as Fishbone, 5 Whys, and FMEA; develop risk-based CAPAs.
Create robust corrective and preventive actions with clear timelines, acceptance criteria, and effectiveness verification plans.
Ensure CAPA documentation and traceability meet FDA, ISO 13485, and internal QMS requirements; collaborate cross-functionally with Quality, Regulatory Affairs, Operations, and Manufacturing Engineering.
Provide technical guidance and mentorship to R&D engineers; support audits with CAPA rationale and technical explanations.
Identify opportunities to improve CAPA execution and contribute to broader quality system and R&D process improvements; operate with autonomy as a technical CAPA authority.
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