Quality Assurance Manager Job California Missouri USA,Quality Assurance

Location: California

Quality Assurance Manager – Valencia & Burbank, CA
Company Benefits

100% employer paid medical and dental
401(k) matching contribution
Generous PTO and paid holidays
Long-term disability
Life and AD&D
Health Care and Dependent Care Flex Spending
Tuition reimbursement
Profit‑sharing program

$110,000 - $140,000 annually (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 Quality Assurance Manager to join our team. The Quality Assurance Manager supports the Director of Quality Operations in maintaining an effective Quality Assurance (QA) program, and GMP Quality Management System which consistently delivers high quality company products. This person audits all activities to verify that appropriate current procedures are followed and keeps the Director of Quality Operations and other designates fully informed, through verbal and written reports and memoranda, on the status of the Quality Systems, Quality Control, and Quality Assurance activities, problems, and customer complaints.

This person and their team assist in maintaining the company’s GMP Quality Management System program.

ESSENTIAL DUTIES

Operates under the guidance of the Director of Quality Operations as necessary, to assure compliance with the company’s GMP Quality Management System program.

Keeps the Director of Quality Operations informed of activities through reports, memos, and meetings.

Oversees ISO 9001, CA‑RHB (Radiological Health Branch‑product registrations, compliance, & licensing), Nuclear Regulatory Commission (NRC), Bureau of Industry & Security (BIS), Customs and Border Protection (CBP), Department of Transportation (Use the "Apply for this Job" box below). CFR / IAEA, DAkkS / ISO 17025, ISO 2919, and NUREG 1556 Vol. 3 Rev. 2 activities.

Maintains GMP QMS through MDSAP (ISO 13485, TG(MD)
R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA (21 CFR 820), FDB, and Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745) CE Mark compliant Quality Management System.

Manages and conducts employee trainings.

Maintains additional quality systems and compliance activities as required.

Maintains the Compliance Program, Corrective Action & Prevention Action (CAPAs) Program.

Oversees the Internal and Supplier Audit Program.

Maintains Supplier Management Program and Quality Control.

Acts as a Lead Auditor and conducts internal, external, and supplier audits, writes audit reports, issues CAPAs and trains internal auditors to conduct these activities.

Conducts compliance reviews and submits establishment and product registrations for NRC/CA‑RHB SS&DRs, RMLs, import/export control, and others as applicable.

Acts as back‑up to the Regulatory Compliance Program. Assists in MDR, MDSAP, CMDR, and other regulatory activities as required.

Conducts customer license reviews and contacts agencies, customers and other external parties as required.

Applies for export licenses from BIS and NRC as required.

Maintains Special Form Radioactive Materials compliance.

Maintains the approval of capsule / package test report documentation and certificates.

Oversees the company’s Document Management Program. Oversees all activities related to document control.

Overs…


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