Assembly Technician

AppleOne is proud to present:
Immediate need for an assembly technician. The Assembly Technician is responsible for accomplishing assembly activities.
Primary responsibilities include assembling devices per provided work instructions, carrying out various production or manufacturing tasks and ensuring compliance with QMS. The role also requires the Assembly Technician to coordinate with other team members to ensure components, equipment, and associated documentation are adequate to maintain production in compliance with the FDA’s Quality System Regulations and ISO 13485:2016. This job is well-suited for an individual who is experienced in assembly processes. This job is full-time, on-site.

Duties and Responsibilities:

• Arriving on time to ensure production takes place a on-time and as scheduled.
• Reading work instructions and participating in assembly training.
• Understanding Critical Innovations’ Quality Management System
• Accurately completing forms and travelers to document production activities.
• Operating various production equipment such as heat sealers, fixtures, and packaging machines.
• Executing regular inventory cycle counts.
• Participating in the receiving, transferring to inventory, and picking of inventory components.
• Operating in a “high mix, low volume” production workflow.
• Accomplishing precise assembly work in a cleanroom environment.
• Working closely with Quality / Engineering to execute verification / validation production runs.
• Identifying manufacturing nonconformities.
• Complying with FDAs Quality System Regulations.
• Performing and documenting work in compliance with ISO 13485:2016 and FDAs Quality System Regulations.
• Ensuring production maintains overall compliance to the Quality Management System.

Skills and Experience:
The Assembly Technician should be able to utilize and develop skills and experience to overcome hurdles that may arise during the production. The following abilities may aid the Assembly Technician in completion of these tasks:

• Ability to quickly learn new production processes.
• Hands-on experience in a production environment.
• Willingness to change directions quickly.
• Excellent Communication, both written and oral.
• Strong problem-solving abilities.
• Must be able to lift 25 lbs.

Preferred Education and Training:

• 2+ years in production or assembly environments.
• Direct experience with cGMP / ISO 13485 requirements.
• Experience operating various forms of production equipment.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here:

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:

https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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Experienced (Non-Manager)