CAPA Owner
On-sitePune, Maharashtra, India
Pune, Maharashtra, IndiaOn-siteFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Lead CAPA investigations from ownership acceptance to closure for Interventional Guided Therapy systems, driving multi-disciplinary teams through root cause analysis and solution development. Create optimized CAPA plans, ensure deliverables meet quality standards, and maintain records in the Quality Case Management tool while communicating progress to global stakeholders. Manage facility improvements and lab resources to support robust, quicker solutions for complex critical issues within the Mechatronics Development Cluster.
Required Qualifications
- An Engineering degree in Mechanical/Electrical/Electronics/Mechatronics or related discipline
- a minimum of 14+ years of relevant experience in professional engineering environment
- a minimum of 5 years' experience in Quality management systems of Medical devices (preferable in ISO13485:2016)
- a minimum of 5 years' experience in development (preferable experience in IEC60601-1)
- Work experience of Handling the CAPA into regulated industry
- Experience of maintaining the Quality Case Management (QCM) tool
- Understanding of CAPA process, key steps, and criteria for success
- Experience of problem solving techniques and tools
- a minimum of 5 years' experience in equipment, labs, and facilitation & requirement definition
- Experience in new product introduction or life-cycle development in the industry
- Good communication skills in English
Desired Qualifications
- 5 years' experience in Quality management systems of Medical devices (preferable in ISO13485:2016)
- preferable experience in IEC60601-1
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