Role: Assoc Sewer
Location: Irvine, CA - 92614
Duration: 6 Months
Job Description:
Applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines.
Key Responsibilities:
• Use tools – needles, scissors, forceps, specialized tooling, microscope – to perform assigned steps, in rotation, in the sewing assembly of valves
• Perform verifications, against specifications, of completed steps, and successive checks on steps completed by work team colleagues
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
• Other incidental duties: General work area housekeeping
Preferred Additional Skills:
•Preferred Previous sewing, GMP, clean room, medical device experience
• Basic computer skills required
• Good hand eye coordination, required
• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Must be able to work in a team environment and with minimum supervision by following detailed manufacturing instructions
• Successful completion of ongoing job training of assembly process steps
• 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
Education/Experience:
• High school diploma or GED required.
• 0-2 years experience required.