Senior Medical Device Packager - GMP & Packaging

Edwards Lifesciences; Irvine (CA); On-site; USD 45,000 - 62,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Packager to support packaging (THV) activities in our California manufacturing environment. You will ensure quality and compliance across labeling, packaging, and warehouse return processing, working closely with manufacturing and QA teams.

Responsibilities include line clearance, peel-testing, and accurate documentation in device history records and JDE, with a focus on detail and adherence to SOPs. Strong English communication required.

Qualifications

• 4 years related experience including GMP, clean room and medical device experience.
• Must be able to read, comprehend, write, and speak English, including giving and receiving feedback.

Responsibilities

• Inspect labels and packaging to ensure quality, regulatory and SOP standards are met; perform outer and inner packaging at a mastered level.
• Package products, generate labels, and apply labels on packaging; re-labeling and packaging of warehouse returns and NCR repairs.
• Perform line clearance by cleaning and sanitizing work stations at shift start and when transitioning to next orders; ensure components and tools are ready for the build.
• Perform integrity peel-testing of inside packaging pouch.
• Follow and perform job functions per work instructions and SOPs; record traceable information on device history records and enter data into JDE.
• Palletize product for outside sterilization services and ensure drawings followed and Biological Indicators placed per SOPs.

Skills

GMP experience

Clean room

Packaging operations

Documentation

Education

HS Diploma or equivalent

Tools

JDE

Job description

Edwards Lifesciences is seeking a Senior Packager to support packaging (THV) activities in our California manufacturing environment. You will ensure quality and compliance across labeling, packaging, and warehouse return processing, working closely with manufacturing and QA teams.

Responsibilities include line clearance, peel-testing, and accurate documentation in device history records and JDE, with a focus on detail and adherence to SOPs. Strong English communication required.