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QA & Regulatory Manager
QA & Regulatory ManagerEckert & Ziegler Isotope Products, Inc. • Valencia, CA, US
QA & Regulatory Manager

QA & Regulatory Manager

Eckert & Ziegler Isotope Products, Inc. • Valencia, CA, US
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  • [job_card.full_time]
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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 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 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 company's 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 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 : Bachelor's degree or equivalent in a scientific related field.
  • Minimum experience required : 5 years of relevant experience in GMP, medical devices, or pharmaceuticals, preferably within a Regulatory-related field, with responsibilities for managing others. 5 years' experience in handling GMP programs, including but not limited to product registrations and customer licensing for FDA, MDSAP and EU MDR (CE Marking), and other international markets.
  • Abilities and skills required :
  • Certified Lead Auditor.
  • Must be able to travel and work in Burbank and in Valencia.
  • Experience with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR / IVD, FDA, QSR / QMSR, ISO standards, and other applicable regulatory requirements.
  • Proven track record of agency interactions, product registrations.
  • Experience in documentation and records administration.
  • Customer service experience and handling customer complaints.
  • Must be able to communicate clearly and succinctly and effectively over the phone, videoconference, and in writing with various clients including regulatory agencies.
  • Strong interpersonal skills, with the ability to communicate effectively at all levels of the organization.
  • Excellent problem solving, prioritizing, and time management skills.
  • Ability to lead and conduct internal, supplier, and customer audits.
  • Strong attention to detail.
  • Experience in design control, manufacturing, process development, quality assurance, quality control.
  • Ability to work independently and in a team environment.
  • Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
  • Proficient in Microsoft Dynamics or equivalent ERP system, Microsoft Office Suite applications (Word, Excel, PowerPoint), Teams, SharePoint, and SmartDraw or equivalent flowcharting program.
  • Able to lift up to 50 lbs.

    • 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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    Compensation details : 00 Yearly Salary

    PI1c4030f0c5fb-4300

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