QA & Regulatory Manager

3 days ago Be among the first 25 applicants

• 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 - $150,000 annually (DOE)

Onsite

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.

Eckert & Ziegler Isotope Products provides sealed and unsealed radiation sources and materials for medical imaging, industrial measurement, oil‑well logging, reference and calibration, environmental monitoring, bulk radioisotopes for pharmaceuticals and industrial manufacturing, source collection, recycling and disposal services, and high‑activity radiation processing and sterilization. The company also supplies medical and industrial irradiators for blood irradiation, sterilization or calibration.

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 and other designates fully informed, through verbal and written reports and memoranda, on the status of QC, QA and Regulatory activities, problems, and customer complaints.

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

• Operate under the guidance of the Director of Quality Operations as necessary to assure compliance with the company GMP Quality Management System program.
• Keep the Director of Quality Operations informed of activities through reports, memos, and meetings and serve as back‑up to the Director.
• Act as the Calibration Laboratory Management Representative.
• Oversee compliance with ISO 9001, MDSAP, FDB, CA‑RHB, NRC, BIS, DOT, DAkkS/ISO 17025, MDMP, and applicable regulations.
• Manage and conduct cGMP and employee trainings.
• Maintain additional quality systems and compliance as required.
• Oversee the Regulatory Compliance Program, Corrective Action & Prevention Action (CAPAs) Program and the Internal Audit Program.
• Conduct internal and supplier audits, write audit reports, issue CAPAs and train internal auditors.
• Conduct regulatory reviews and submit product registrations for NRC, CA‑RHB, CMDR, FDA, MDD/MDR, import/export control, and others as applicable.
• Conduct customer license reviews and contact regulatory agencies and customers as required.
• Apply for export licenses from BIS and NRC as required.
• Support Special Form Radioactive Materials compliance.
• Support the approval of capsule/package test report documentation and certificates.
• Oversee the company’s Document Management Program.
• Conduct revision of old procedures to maintain Quality Control and Assurance of the products.
• Have final approval on all controlled procedures, procedure revisions, Engineering Drawings and Engineering Change Orders.
• Support all activities related to documentation control.
• Be responsible for the Customer Complaints and Returns program.
• Evaluate customer complaints and assist in maintaining the returned sources program; have final approval of Complaints and Returns reports.
• Assist in scheduling, participating, follow‑up or leading audits as required.
• Manage the company‑wide training program by formulating and conducting Quality and Regulatory training.
• Interview employment candidates and make hiring suggestions to upper management.
• Plan, assign, and direct work.
• Set/oversee department goals and objectives and work toward reaching those goals.
• Train and motivate employees.
• Conduct employee performance appraisals.
• Rew…