Quality Assurance Manager (Valencia)

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:

1. Operates under the guidance of the Director of Quality Operations as necessary, to assure compliance with the company’s GMP Quality Management System program.
2. Keeps the Director of Quality Operations informed of activities through reports, memos, and meetings.
3. 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 ( DOT) 49 CFR / IAEA, DAkkS / ISO 17025, ISO 2919, and NUREG 1556 Vol. 3 Rev. 2 activities.
4. 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.
5. Manages and conducts employee trainings.
6. Maintains additional quality systems and compliance activities as required.
7. Maintains the Compliance Program, Corrective Action & Prevention Action (CAPAs) Program.
8. Oversees the Internal and Supplier Audit Program.
9. Maintains Supplier Management Program and Quality Control.
10. 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.
11. Conducts compliance reviews and submits establishment and product registrations for NRC/CA-RHB SS&DRs, RMLs, import / export control, and others as applicable.
12. Acts as back-up to the Regulatory Compliance Program. Assists in MDR, MDSAP, CMDR, and other regulatory activities as required.
13. Conducts customer license reviews and contacts agencies, customers and other external parties as required.
14. Applies for export licenses from BIS and NRC as required.
15. Maintains Special Form Radioactive Materials compliance.
16. Maintains the approval of capsule / package test report documentation and certificates.
17. Oversees the company’s Document Management Program. Oversees all activities related to document control.
18. Oversees, manages, and conducts revision process of old procedures as necessary to maintain Quality Control and Quality Assurance of the products.
19. Has final approval on all controlled procedures, procedure revisions, Engineering Drawings, and Engineering Change Orders.
20. Supports the Customer Complaints and Returns program.
21. Evaluates customer complaints, with input from Sales as needed, and assists in the maintenance of the returned sources program. Has final approval of Complaints and Returns reports.
22. Oversees the company wide training program by scheduling, formulating and conducting training.
23. Interviews employment candidates and makes hiring suggestions to upper management.
24. Plans, assigns, and directs work.
25. Sets / oversees department goals and objectives and work towards reaching those goals.
26. Trains and motivates employees.
27. Conducts employee performance appraisals.
28. Rewards and disciplines employees, addressing complaints and resolving problems.
29. Travel required at various times to Burbank and Valencia facilities, and for supplier audits and training.
30. Performs other duties as required by management.

Requirements:

1. Minimum education (or substitute experience) required: Bachelor’s degree or equivalent in a scientific related field.

1. Minimum experience required: 5 years of relevant experience in Quality Assurance and Quality Systems, medical devices, or pharmaceuticals, preferably within a Regulatory-related field, with responsibilities for managing others. 5 years’ experience in handling Quality Assurance programs, including but not limited to Quality Control, Supplier Management, Document Management, Audits, Quality Systems (software and related quality software programs). Regulatory Compliance experience desired.

1. Abilities and skills required:

• Certified Lead Auditor.
• Must be able to travel and work in Burbank and in Valencia.
• Experience with Quality Assurance, Quality Control, Quality Systems, ERP, Document and Records Administration, Internal and External Audits, and Supplier Management.
• Proven track record in managing a Quality Assurance program.
• Customer service experience and handling customer complaints, CAPAs, and agency interaction.
• Must be able to communicate clearly and succinctly and effectively over the phone, videoconference, and in writing with various clients including customers and external 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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