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Chief Quality Specialist
3 weeks ago
Monitor and control customer processes to ensure satisfaction.
You will have a customer interface for Quality metrics and improvement initiatives.
- Develop and improve quality processes.
- Perform in-process testing on products.
- Complete weekly leak & burst testing to verify product sealing.
- Verify critical process parameters (CPPs) and Line Clearance activities.
- Audit internal processes for conformance and effectiveness.
Support audits by demonstrating product testing requirements and best practices.
Identify improvements through quality reviews and meetings.
Escalate quality issues when necessary and conduct non-conformance investigations.
Sample the ISO Class 8 Cleanrooms weekly.
Prepare and review sterile release packs, including Endotoxin and Bioburden test reports.
Conduct and verify releasing of sterile products.
Support SMT line first-off verifications and verify Line Clearance activities.
Review and approve unplanned maintenance activities across assembly lines.
Determine lot suitability for release by reviewing production logs and final batch records against product specifications, procedures, and electronic data systems.
Review and approve Design History Records (DHR) by obtaining and verifying DHR contents against documentation requirements.
Interact with manufacturing execution system (MES) and Oracle Agile systems daily to ensure product assembly meets specifications.
Ensure ongoing compliance with quality and industry regulatory requirements.
Comply with Health & Safety Legislation and Regulations.
