Assembler

Details:

Stefanini Group is hiring!

Stefanini is looking for Assembler in Irvine, CA

For quick Apply, please reach out to Vipul Bhardwaj - call: 2482638630/ email: vipul.bhardwaj@stefanini.com

Work Hours: M-F (40 hours)

Work Location: Irvine, CA

Shift: 2nd Shift (3:00 PM to 11:30 PM)

Summary

(Main purpose of the job)

• Assembles and packs medical devices in a clean room/non-clean room environment following written and verbal specifications while performing the following duties.
• Essential Duties and Responsibilities
• (List of Primary responsibilities of this role that account for 50% or more of the work. Incumbent may perform other duties as assigned.)
• Assembles medical devices following strict GMP''s, specifications and procedures.
• Availability to rotate in different operations within the manufacturing process/training module assigned.
• Collaborates effectively within teams to foster strong relationships and minimize conflicts, promoting a harmonious work environment.
• When needed, may be requested to document data or results regarding manufacturing processes and assure that the information is accurate and according to GDP''s.
• Able to determine quality of product at each stage of development and communicate issues and deviations regarding products and process immediately.
• Perform in-process quality inspections and checks including but not limited to visual inspection of devices, visual inspection of packaging materials, and air flow testing of devices.
• Able to document actions, data, or results regarding manufacturing processes and assures that the information is accurate and according to good documentation practices.
• Must be able to use sanitizer as part of the gowning process when entering the cleanroom.
• Perform cleaning and organization of manufacturing equipment, tools, and supplies.
• Demonstrates exceptional manual dexterity in performing intricate tasks, including assembly, or precision handling of tools and materials, ensuring high-quality and attention to detail.
• Able to exercise caution when handling product, materials, or tools to avoid damages, or scrap generation.
• Must be able to follow Safety requirements, instructions, and procedures.
• This position requires to be on-site to be able to perform the essential functions of the position.
• Must be able to use appropriate Personal Protective Equipment (PPE) such as appropriate gown, eye wear, face protection, shoe covering, and gloves.
• Must be able to work all scheduled hours including overtime.

Qualifications

• (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)
• Ability to pass visual acuity test (20/20 corrected vision) and pass Particulate Matter Certification
• Ability to read and comprehend manufacturing procedures.
• Ability to read, write, and understand English.
• Ability to communicate with leads and supervisors.

Education and/or Experience

• High School Diploma, GED, or equivalent.
• The physical demands and working environment described here are representative of those that must be met by an employee.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.