Senior Packager, Pilot

How you'll make an impact:

• Inspect labels and packaging to ensure quality, regulatory and SOP standards are strictly met. Perform both outer and inside packaging procedures, at a fully mastered level while working independently at the highest levels of quality and productivity.
• Package products, generate labels, and place labels on packaging, in strict keeping with quality, regulatory and SOP standard as well as perform re-labeling and packaging of warehouse returns and NCR repairs.
• Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Ensure all required components and tools are ready for the build.
• Perform integrity peel-testing of inside packaging pouch.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE (issuing packaging materials from floor stock inventory).
• Palletize product to send to outside sterilization services, ensuring drawings are followed and that Biological Indicators are placed correctly per SOPs.

What you'll need (Required):

• 4 years related experience required including GMP, clean room, medical device experience.
• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English, including giving and receiving feedback.

What else we look for (Preferred):

• H.S. Diploma or equivalent.
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures.
• Must be able to work with minimum supervision by following detailed manufacturing instructions as well as work in a Team environment, primarily work with colleagues and supervisor and may also work on inter-departmental teams.
• Strict attendance 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 required with in-depth understanding of documentation and JDE transactions.
• Provide training, and may provide coaching to more junior employees. Evaluate and demonstrate correct approach on work of other employees, in the absence of the Lead.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.