Capa专员

Abbott

Hangzhou, China
Not specified
Capa project management experience
Six sigma root cause analysis skills
Cross-functional team collaboration
Abbott is seeking a CAPA Specialist for their Hangzhou location, responsible for managing CAPA projects, ensuring compliance, and collaborating with cross-functional teams. The ideal candidate should possess at least two years of experience in CAPA or quality assurance within the medical device sector and be fluent in English

Job Summary

  • The role involves leading or participating in CAPA projects to ensure compliance and timeliness of quality records.
  • Candidates must possess strong problem-solving skills using methodologies like Six Sigma for root cause analysis.
  • The position requires fluency in English and familiarity with ISO13485 standards and Chinese medical device regulations.

Matching Summary

Match Score: 85

Abbott is seeking a CAPA Specialist for their Hangzhou location, responsible for managing CAPA projects, ensuring compliance, and collaborating with cross-functional teams. The ideal candidate should possess at least two years of experience in CAPA or quality assurance within the medical device sector and be fluent in English.

Skills & Requirements

Must-have

  • CAPA project management experience
  • Six Sigma root cause analysis skills
  • Cross-functional team collaboration
  • Electronic system record processing
  • ISO13485 standard familiarity

Nice-to-have

  • Internal auditor certification
  • Fluent English communication skills
  • Continuous improvement initiatives
  • Audit and inspection support
  • Training program oversight

Key Requirements

  • Bachelor's degree in Engineering, Pharmacy, Biology, or related field
  • At least 2 years of CAPA or Medical Device QA experience
  • Quality management system internal auditor certificate
  • Proficiency in Microsoft Office software (Word, Excel, PowerPoint)

Work Rights

Not specified

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