Senior Medical Device Packager — GMP & Quality Focus

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

Job summary

Edwards Lifesciences in Irvine, CA seeks a Senior Packager to support packaging and line clearance in GMP clean room. You will inspect labels, package products, generate and apply labels, and assist with packaging operations on a fast-paced manufacturing line.

Requires 4+ years in GMP/clean room medical device environments, strong attention to detail, and ability to work with minimal supervision. Training and teamwork are essential in this role at Edwards Lifesciences.

Qualifications

• 4+ years of related experience including GMP and clean room
• Ability to read, write, and speak English
• Able to work with minimal supervision and follow detailed manufacturing instructions

Responsibilities

• Inspect labels and packaging to ensure quality, regulatory and SOP standards are met
• Package products, generate labels, and apply labels per SOP
• Perform line clearance, cleaning and sanitizing work stations at shift start and when switching to next work orders
• Perform integrity peel-testing of inside packaging pouch
• Record traceable information on device history records and enter data into JDE
• Pallete product for outside sterilization services and ensure compliance with drawings and SOPs

Skills

GMP experience

Clean room

Medical device experience

Attention to detail

Teamwork

Documentation

Basic computer skills

Education

HS Diploma or equivalent

Tools

JDE

Job description

Edwards Lifesciences in Irvine, CA seeks a Senior Packager to support packaging and line clearance in GMP clean room. You will inspect labels, package products, generate and apply labels, and assist with packaging operations on a fast-paced manufacturing line.

Requires 4+ years in GMP/clean room medical device environments, strong attention to detail, and ability to work with minimal supervision. Training and teamwork are essential in this role at Edwards Lifesciences.