Description

You will manage specification, qualification, and validation requirements for implants and instruments. You own the engineering change orders related to CAPAs, CTQs, aging reports, and design history files.

Responsibilities

• Conduct risk-based verification for GxP systems (GMP, GCP, GLP) and laboratory equipment.
• Create and update Failure Mode and Effect Analysis (DFMEA) for new products.
• Design and oversee validation components, inspection plans, and Inspection Feature Assessments.
• Perform Gap Analysis to ensure compliance and identify areas for improvement.
• Apply Kaizen methodologies to optimize validation processes.

Required Skills

• Bachelor’s degree in Science, Technology, Engineering, or a related field.
• At least 12 months of experience in validation or a related occupation.
• Proficiency with AutoCAD and CATIA for design and specification.
• Experience using MATLAB and Python for data analysis and scripting.
• Knowledge of Ansys for simulation and Minitab for statistical analysis.
• Familiarity with Tally and GxP environments.
• Ability to perform Gap Analysis effectively.

Preferred Skills

• Experience with Kaizen principles in a manufacturing or validation context.

Key Skills

Education

Any Graduate