Sr. Packaging Verification %26 Validation Engineer
3 weeks ago
- Bachelor%26rsquo;s Degree in Engineering or equivalent knowledge.
- At least 4 years with verification or validation testing.
- Experience analyzing and reporting data in order to identify issues, trends, or exceptions.
- Experience evaluating information to determine compliance with standards, laws, and regulations.
- Experience investigating and owning device packaging nonconformances and CAPA
- Experience interacting with regulatory auditors.
- Experience with process improvement and project management.
- Experience with IQ/OQ/PQ equipment qualifications for packaging test equipment.
- Equipment in scope includes but is not limited to vibration table, drop tester, compression tester, and environmental chambers.
- Experience with Test Method Validation strategies such as Gage R&R and Attribute Agreement Analysis.
- Demonstrated experience in designing, developing, and qualifying medical device packaging. Proven ability to design packaging and packaging components to meet specifications within project timelines
- Effective communication of technical knowledge of packaging test methods, standards, and equipment.
- Knowledge of the following standards: ISO 11607-01, ISO 11607-02, ISO 16775, ISO 13485, ISO 14971, EU MDR, ASTM D4169, ASTM D7386, ISTA 3A, UDI.
784333
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Mundelein, United States Healthcare Businesswomen's Association Full timeJOB SUMMARY: Under limited supervision, lead verification and validation activities related to medical device product packaging. Ensure regulatory compliance by inspecting, measuring, analyzing, auditing, calibrating and testing instrumentation, equipment, software/hardware, machines and/or procedures. Identify problems and their sources and correct them...
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Sr. Packaging Verification
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