Were looking for a proactive QA Quality Engineer to support our Quality Assurance function and ensure our products and processes meet the highest regulatory and quality standards.
What youll do:
1. Evaluate Manufacturing and Quality processes for compliance with ISO 13485, GMP, and FDA 21 CFR 820.
2. Support Quality, Manufacturing and cross-functional teams with investigations, documentation, and continuous improvement.
3. Support continuous improvement to manufacturing process through NCRs, root cause analysis and risk management activities.
4. Support internal audits.
5. Review/approve SOPs and product/equipment specifications.
6. Adhere to Quality Management System (QMS) requirements in line with Corins Good Manufacturing Practice (GMP) as per ISO13485 & FDA21 CFR Part 820.
7. Work with multiple stakeholders internally; R&D, Operations and Validation plus many othe...