QA/QC Specialist
Company Benefits
$28.00 - $32.00 hourly (DOE)
Position is Onsite
Company Overview
Contributing to Saving Lives
The Eckert & Ziegler Group is one of the world's largest providers of isotope technology for medical, scientific, and industrial use. The core businesses of the Group are Diagnostic Nuclear Medicine Imaging, Cancer Therapy, and Industrial Radiometry.
Business Segment Overview
Eckert & Ziegler Isotope Products provides sealed and unsealed radiation sources and materials for Medical Imaging sources; Industrial sources for measurement and analysis; Oil Well Logging sources and related products; Reference, Calibration and Environmental Monitoring sources and solutions; Bulk radioisotopes for pharmaceutical, therapeutic and industrial product manufacturing; Services for collection, recycling and disposal of sources and low-activity waste; Sources for industrial Non-Destructive Testing; High-Activity radiation sources for radiation processing and sterilization; Medical and Industrial irradiators for blood irradiation, sterilization or calibration.
The Job
Eckert & Ziegler Isotope Products seeks a QA/QC Specialist to join our team. The QA/QC Specialist assists the Quality Systems Manager (Burbank facility), Regulatory Manager or Radioassay Manager (Valencia facility) in maintaining an effective Quality Control Program, which consistently delivers high quality Company products on time. This person participates in quality inspections to verify that appropriate current procedures are followed and keeps the Quality Systems Manager or Regulatory Manager or Radioassay Manager fully informed on status of QC/QA activities.
ESSENTIAL 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 Company 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 Company 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 the Company’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:
Minimum education (or substitute experience) required: Minimum of High School Diploma, college degree preferred.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.Abilities and skills required:Must be able to travel and work in Valencia and Burbank.Excellent communication, verbal, and writing skills.Strong attention to detail.Proficient in use of calipers, optical calibrator, micrometers.Able to perform Final QC and Receiving Inspection.Ability to work independently and in a team environment.Excellent planning, organization, and flexibility to adjust to a rapidly changing environment. Able to lift up to 50 lbs.Proficient in Microsoft Excel, Word, and Access.We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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