General Job Duties:
• Operates under the guidance of the Quality Systems Manager, Regulatory Manager or Radioassay Manager to assure compliance with the Company Quality Control and Quality Assurance Program.
• Communicates with the Quality Systems Manager, Regulatory Manager or Radioassay Manager on QA/QC activities through reports and meetings.
• Assists in maintaining an ISO 9001, MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA (21 CFR 820)), FDB, CA-RHB (Radiological Health Branch-product registrations, compliance, & licensing), Nuclear Regulatory Commission (NRC), Bureau of Industry & Security (BIS), DOT 49 CFR / IAEA, DAkkS / ISO 17025 , and Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745) CE Mark compliant Quality Management System..
• Assists in maintaining additional regulatory systems and compliance as required.
• Conduct final QC on all EZIP product lines and performs final QC on all orders except those specified by the Quality Systems Manager, Regulatory Manager or Radioassay Manager.
• Responsible for issuing, processing, closing, and filing of NCRs.
• Conducts filing, organizing, and record keeping of all QC documentation.
• Observes production and verifies procedures are being followed.
• Recommends procedure changes where improved techniques will facilitate production, etc.
• Performs incoming receiving inspection as required.
• Performs inspection for accuracy and legibility on all engravings performed in-house or by outside vendors, as appropriate.
• Aids in conducting dimensional QC on components manufactured in-house or by outside vendors, as appropriate.
• Performs license compliance reviews on domestic (NRC / State) and international (Export Control) sales orders.
• Maintains the EZIP Document Management Program.
• Conducts revision process of documents as necessary to maintain Quality Control and Quality Assurance of the products.
• Assists in the maintenance of EZIP’s Quality System documentation, including procedures, forms,
drawings, transmittals, quality & company records, external standards.
• Maintains all activities related to documentation and records control including electronic systems to manage these (BPM, eQMS, DocuWare, or as applicable).
• Approves design control drawings and ECO (Engineering Change Orders).
• Supports maintenance of technical files for CE Marking/medical devices and other products.
• Conducts internal and supplier audits under the supervision of a Lead Auditor.
• Trains employees on QC / QA procedures and inspection processes, as required.
• Travel required at various times to Burbank and Valencia facilities, and for supplier audits and training.
• Performs other duties as required by management.

Requirements:
1. Minimum education (or substitute experience) required: Minimum of High School Diploma, college
degree preferred.
2. Minimum experience required: Minimum 3 years of experience with Quality Control or Quality
Assurance. One year of experience with light documentation control such as filing, organization of
paperwork, and inventory logs.
3. Experience in the following areas:
o Must be able to travel and work in Valencia and Burbank.
o Excellent communication, verbal, and writing skills.
o Strong attention to detail.
o Proficient in use of calipers, optical calibrator, micrometers.
o Able to perform Final QC and Receiving Inspection.
o Ability to work independently

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, AppleOne 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.