QA & Regulatory Manager Job Santa Clarita area,California USA,Quality Assurance

Position: QA & Regulatory Manager

Quality Assurance & Regulatory 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

Pay: $110,000 - $150,000 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 & Regulatory Manager to join our team. The Quality Assurance and Regulatory 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 QC, and QA and Regulatory activities, problems, and customer complaints.

This person and their team assist in maintaining the companys 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 GMP Quality Management System program.

Keeps the Director of Quality Operations informed of activities through reports, memos, and meetings;
Serves as back-up to the Director of Quality Operations.

Acts as the Calibration Laboratory Management Representative for the company.

Oversees on 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.

Manages and conducts cGMP and employee trainings.

Maintains additional quality systems and compliance as required.

Oversees the Regulatory Compliance Program, Corrective Action & Prevention Action (CAPAs) Program and the Internal Audit Program.

Conducts internal and supplier audits, writes audit reports, issues CAPAs and trains internal auditors to conduct these activities.

Conducts regulatory reviews and submits product registrations for NRC/CA-RHB SS&DRs, CMDR licenses, RMLs, FDA, MDD/MDR, import / export control, and others as applicable.

Conducts customer license reviews and contacts regulatory agencies and customers as required.

Applies for export licenses from BIS and NRC as required.

Supports Special Form Radioactive Materials compliance.

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

Oversees the companys Document Management Program.

Oversees, manages, and conducts revision process of old procedures as necessary to maintain Quality Control and Quality Assurance of the products.

Has final approval on all controlled procedures, procedure revisions, Engineering Drawings, and Engineering Change Orders.

Supports all activities related to documentation control.

Responsible for the Customer Complaints and Returns program.

Evaluates customer complaints, with input from Sales as needed, and assist in the maintenance of the returned sources program. Has final approval of Complaints and Returns reports.

Assists in scheduling, participating, follow-up, or leading audits as required.

Manages the company wide training program by formulating and conducting Quality and Regulatory training.

Interviews employment candidates and make hiring suggestions to upper management.

Plans, assigns, and directs work.

Sets / oversees department goals and objectives and work towards reaching those goals.

Trains and motivates employees.

Conducts employee performance appraisals.

Rewards and disciplines employees, addressing complaints and resolving problems.

Travel required at…


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