Job Description:
Duties:
- Manage specification, qualification and validation requirements.
- Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files.
- Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment.
- Create, and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments.
- Design, develop and oversee validation components and work on inspection plans and Inspection Feature Assessment.
Skills Required – AutoCad, Matlab, Kaizen, Minitab, Tally, Catia, Python, Ansys and Gap Analysis.
Requirement:
Bachelor’s degree in Science, Technology, Engineering, or any related field along with 12 months of experience in job offered or related occupation is required.