Summary:In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards.
Roles & Responsibilities:- Develop and execute validation plans and reports.
- Analyze data and troubleshoot process deviations.
- Ensure compliance with FDA regulations and ISO standards.
- Collaborate with Engineering and Quality teams to drive continuous improvement.
Required Qualifications:- 8+ years of validation experience in the medical device or other regulated industry.
- Strong expertise in injection molding and plastic materials.
- Hands-on experience with cleaning validation and contamination control.
- Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
