Sr. Packaging Verification %26 Validation Engineer

3 weeks ago


Mundelein, United States Medline Industries Full time
EDUCATION
  • Bachelor%26rsquo;s Degree in Engineering or equivalent knowledge.
WORK EXPERIENCE
  • At least 4 years with verification or validation testing.
KNOWLEDGE / SKILLS / ABILITIES
  • 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
PREFERRED JOB REQUIREMENTS
  • 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
PREFERRED KNOWLEDGE / SKILLS / ABILITIES
  • 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.

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