Assembler

Stefanini Group; Irvine (CA); On-site; USD 25,000 - 33,000; Full time

Job summary

Stefanini Group is seeking an Assembler in Irvine, CA, onsite, for the 2nd shift to assemble and pack medical devices in a clean room environment. You will follow GMPs, participate in various manufacturing operations, and ensure accurate documentation and quality checks throughout the process.

Candidates must have a High School Diploma or GED, pass vision and particulate matter tests, and be able to read and understand English, with strong attention to detail and teamwork required.

Qualifications

• High School Diploma, GED, or equivalent.
• 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.

Responsibilities

• Assembles medical devices following GMPs, specifications and procedures.
• Available to rotate in different operations within the manufacturing process/training module assigned.
• Collaborates effectively within teams to foster relationships and minimize conflicts.
• May document data or results regarding manufacturing processes and ensure information is accurate per GDPs.
• Determine quality of product at each development stage and communicate issues promptly.
• Perform in-process quality inspections and checks including visual inspection of devices and packaging materials.

Skills

GMP compliance

Manual dexterity

Team collaboration

Documentation

Education

High School Diploma / GED

Job description

Join us to co-create solutions for a better future!

Stefanini is looking for Assembler in Irvine, CA (Onsite)

Work Hours: M-F (40 hours)

Work Location: Irvine, CA (Onsite)

Shift: 2 nd Shift

Assembles and packs medical devices in a clean room/non-clean room environment following written and verbal specifications while performing the following duties.

Responsibilities

• 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 products, materials, or tools to avoid damage, 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.

Job Requirements

Details:

• High School Diploma, GED, or equivalent.
• 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.

Physical Demands & Working Environment

The physical activity of this position

• Fingering. Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
• Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing. Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations sound.
• Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers – as related to administrative work.

The physical requirements of this position

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

The visual acuity requirements include color, depth perception, and field vision

• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes

The conditions the worker will be subject to in this position

• None. The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)
• The worker is subject to noise. There is sufficient noise to cause the worker to shout in order to be heard above ambient noise level.
• The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.