Senior Packager, Pilot

Edwards Lifesciences•Irvine, CA

18d•$45,000 - $62,000

About The Position

The Senior Packager performs transcatheter heart valve (THV) packaging work to support manufacturing and production activities, following established procedures and guidance. The role works independently at a fully mastered level to meet high standards of quality and productivity. It includes packaging and labeling products, inspecting packaging, maintaining workstations, and preparing products for outside sterilization services. The position also requires compliance with quality, regulatory, environmental health and safety, and standard operating procedure requirements, as well as accurate documentation and, when applicable, JDE transactions.

Requirements

At least 4 years of related experience, including GMP, clean room, and medical device experience.
Ability to read, comprehend, write, and speak English, including giving and receiving feedback.
Ability to complete, retain, and incorporate training coursework when performing new and advanced work procedures.
Ability to work with minimum supervision by following detailed manufacturing instructions and to work in a team environment.
Attention to detail and ability to comply with standards.
Ability to perform all packaging operations.
Full understanding of manufacturing procedures and pouch peel-test integrity operations.
Good computer skills, including an in-depth understanding of documentation and JDE transactions.
Ability to adhere to Edwards Environmental Health and Safety and Quality guidelines for clean room medical device manufacturing.

Nice To Haves

High school diploma or equivalent.

Responsibilities

Inspect labels and packaging to ensure quality, regulatory, and SOP standards are met.
Perform inside and outside packaging procedures independently at high levels of quality and productivity.
Package products, generate and apply labels, and relabel and package warehouse returns and NCR repairs.
Perform line clearance by cleaning and sanitizing workstations at the start of shifts and when transitioning between work orders; ensure required components and tools are ready for builds.
Perform integrity peel-testing of inside packaging pouches.
Follow work instructions and SOPs, record traceable information on device history records, and enter information into JDE when applicable, including issuing packaging materials from floor stock inventory.
Palletize products for outside sterilization services, following drawings and placing Biological Indicators correctly according to SOPs.
Provide training and, when the Lead is absent, coach junior employees and evaluate and demonstrate the correct approach to their work.
Follow company rules and requirements, including pandemic and Environmental Health and Safety protocols, and take control measures to prevent injuries and pollution.