Medical Device Assembler

Kelly Services; Irvine (CA); On-site; USD 60,614,000 - 64,747,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Holiday pay

Transit benefits

Paid sick leave

Job summary

Kelly Services is seeking a Medical Device Assembler in Irvine, CA. The role involves assembling, inspecting, and packaging medical devices in cleanroom and non-cleanroom environments, following GMPs, GDPs, and written procedures.

You will rotate across manufacturing operations and document activities accurately. The position requires high school diploma or GED, strong attention to detail, and ability to read/write English.

Qualifications

• High school diploma or GED required.
• Ability to read, write, and understand English.
• Ability to follow manufacturing procedures and written instructions.
• Able to communicate effectively with Leads and Supervisors.
• Ability to pass a visual acuity test (20/20).
• Experience in medical device, manufacturing, cleanroom, assembly, or packaging is preferred.

Responsibilities

• Assemble and package medical devices according to specifications and GMP requirements.
• Rotate between manufacturing operations and complete required training.
• Perform in-process quality inspections and airflow testing.
• Document manufacturing activities and results in GDP-compliant manner.
• Maintain cleanroom PPE and gowning procedures as required.
• Work on-site, observe safety instructions, and participate in overtime when needed.

Skills

Manual dexterity

Attention to detail

Quality inspection

Written and verbal communication

GMP/GDP familiarity

Education

High school diploma or GED

Job description

Medical Device Assembler

Location: Irvine, CA

Shift: 2nd

Work hours: 3:00PM to 11:30PM

Word days: M-F

Pay Rate: $22HR

Position Summary

The Medical Device Assembler assembles, inspects, and packages medical devices in cleanroom and non-cleanroom environments. The position requires strict adherence to Good Manufacturing Practices (GMPs), written procedures, safety requirements, and Good Documentation Practices (GDPs).

Essential Responsibilities

• Assemble and package medical devices according to approved specifications, procedures, and GMP requirements.
• Rotate between assigned manufacturing operations and complete required training.
• Perform in-process quality inspections, including visual inspection of devices and packaging materials and airflow testing.
• Identify and immediately report product defects, process issues, and deviations to Leads or Supervisors.
• Accurately document manufacturing activities, data, and results according to GDP requirements.
• Clean and organize manufacturing equipment, tools, and supplies.
• Use proper PPE, including gowns, eye protection, face protection, shoe covers, and gloves.
• Follow cleanroom gowning procedures, including the use of sanitizer.
• Handle products, materials, and tools carefully to prevent damage and scrap.
• Work collaboratively with team members to maintain a productive and respectful work environment.
• Work on-site and complete all scheduled hours, including overtime when required.
• Follow all company safety instructions, procedures, and requirements.

Qualifications

• High school diploma, GED, or equivalent.
• Ability to read, write, and understand English.
• Ability to read and follow manufacturing procedures and written instructions.
• Ability to communicate effectively with Leads and Supervisors.
• Ability to pass a visual acuity test, including 20/20 corrected vision.
• Ability to pass Particulate Matter Certification.
• Strong attention to detail and manual dexterity.
• Previous medical device, manufacturing, cleanroom, assembly, or packaging experience is preferred but not required.

Physical and Work Environment Requirements

• Perform repetitive movements involving the hands, wrists, and fingers.
• Use close visual acuity for inspecting small parts, defects, packaging, and assembled devices.
• Distinguish color, depth, and field of vision.
• Sit, stand, walk, reach, and perform detailed assembly tasks as required.
• Exert up to 10 pounds of force occasionally and minimal force frequently.
• Communicate and hear at normal speaking levels; some areas may require speaking above ambient noise.
• Work near moving equipment, vehicles, electrical current, chemicals, and other manufacturing-related hazards while following all safety procedures.
• Wear required cleanroom garments and PPE for extended periods.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and ...