Auditing, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Failure Mode and Effects Analysis (FMEA), Healthcare Quality, Maintain Compliance, Medical Equipment, Process Improvement, Process Validation, Quality Engineering, Quality Management, Regulatory Compliance, Risk Analysis, Risk Management, Vendor/Supplier Evaluation, Vendor/Supplier Quality Management
Job Summary:- 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.
Roles & Responsibilities:- 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:- 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.
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Katalyst Healthcares & Life Sciences