KH
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
5 months ago
- CAPA
- Risk Management
- FMEA
5 months ago
- We are seeking a Supplier Quality Engineer to support supplier transfer activities and ensure compliance with quality and regulatory standards.
- The role involves validation execution, supplier quality management, and driving continuous improvement initiatives.
- Lead supplier transfer and qualification activities
- Execute validations (IQ/OQ/PQ)
- Manage quality agreements with suppliers
- Handle Client/CAPA investigations and resolutions
- Conduct supplier audits and ensure compliance
- Perform risk management activities (FMEA, risk assessments)
- Experience in supplier quality within medical device or regulated industry
- Strong knowledge of IQ/OQ/PQ validations
- Hands-on experience with Client/CAPA and audits
- Familiarity with risk management processes
- Ability to work onsite and start immediately.
Supplier Quality Engineer · Katalyst Healthcares & Life Sciences