Vacancy expired!
- Manage and execute packaging changes to drive margin improvements, while ensuring current state performance,
- Specify, design, verify and validate packaging in accordance with applicable medical regulatory standards.
- Develop packaging specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements through completion.
- Prepare Quality Plans, Design Change Plans, Master Validations Plans, protocol, and written reports.
- Evaluates process and design alternatives based on "design for manufacturability" principles.
- Troubleshoots to determine optimal run ability of packaging.
- Communicate effectively and participate on cross functional development teams.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,
- Packaging testing for all types of packaging including cartons, corrugate, labels, pouches, thermoform trays, etc.
- Excellent firsthand working knowledge medical device package testing as well as proficient working knowledge of ASTM standards associated with medical device package testing.
- BS in Packaging, Mechanical, or Manufacturing Engineering,
- 5-10 years packaging industry experience, 3-5 year in med device/pharma industry,
- Proficient and extensive working knowledge of packaging material and suppliers' processes.
- Subject matter expert of ISO 11607 part I & part II
Vacancy expired!