Are you an organized and process-oriented thinker with experience in Quality Systems in the medical device industry? If your answer is YES, then we would like to speak to you about an exciting career growth opportunity!

Kerr, a subsidiary of Sybron Specialties, manufactures and sells products for restorative and aesthetic dentistry, focusing on 4 key product categories: Cements, Bonding Agents, Impression Materials and Composites. These are consumables and are the type of materials a dentist uses on a daily basis for many common procedures. Kerr also sells some small equipment such as the award-winning Demetron Curing Light.

JOB SUMMARY: Reporting to the Sr. QA Manager, the Quality Systems Supervisor ensures that core functions of Quality Assurance are consistently in compliance with regulatory requirements and corporate standards. This involves assuring quality standards (FDA, ISO, CMDCAS, and MDD requirements) are with respect to such process as Document Controls, CAPA, Nonconforming Materials, Complaints, and Internal Auditing. KEY RESPONSIBILITIES: • Ensures FDA QSR (GMP), ISO 13485, MDD, CMDCAS, and other regulatory and/or national and international standards as applicable are continuously met. • Maintains quality systems in compliance with all applicable regulatory standards as above and other relevant requirements throughout the facility. • Prepares trend analyses, memoranda and other communications for and on behalf of management which may be called for from time-to-time. • Identifies and oversees Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities. • Handles complaint system/process, including evaluation and closure, of product/shipping complaints. Interact with Customer Service Department as to all matters involving customer complaints and their resolution. • Responsible for the document control process, including oversight over Engineering Change process, creation and revision of standard operating procedures evaluation. • Liaises with SDS Regulatory Affairs as it relates to new product, MDR/vigilance reporting, product licensing/registrations and other regulatory or compliance issues. • Oversees the documentation process for Device History Records; propose, draft, review and approve new or revised SOP, job instructions and related forms relative to the quality assurance program or other programs which may impact the quality assurance program. • Supervises 7 direct reports and responsible for hiring and training of quality assurance personnel.

MAIN CRITERIA: The Quality Systems Supervisor must have knowledge of FDA Medical Device Regulations, FDA process validation guidelines, ISO 13485 quality programs and Quality System Guidelines. • 3-5 years of experience in a medical device or FDA compliant industry required. • Knowledge of Code of Federal Regulations 21 CFR Part 820 required. • Strong project management and organizational skills. • Excellent verbal and written communication skills with ability to interface and influence cross functional teams. • Knowledgeable of the proper handling of chemicals and waste, both hazardous and nonhazardous, as defined by FDA, OSHA, EPA and DOT. • Proficiency with MS-Office suite. • Supervisory experience, a PLUS! • Southern California candidates only.

EDUCATION: • Bachelor Degree required, preferably in a Science or Quality Management discipline. BENEFITS: • Sybron Dental Specialties recognizes the innovation and energy of its employees with competitive compensation and a full range of benefits, including medical/dental/vision, retirement plan, and much more.

TO APPLY: Please visit our website at: http://www.sybrondental.com/jobopenings.php with Job Number: SYB000125

At Sybron Dental Specialties, we develop innovative technologies and manufacture and market products for the dental and medical professions serving clinicians worldwide and, ultimately, improving the health and beauty of their patients. In the dental space, we address implants, endodontics, restorative dentistry, and orthodontic markets. On the medical side, in conjunction with dental, we offer high-quality infection prevention and magnification/illumination products for the healthcare professional. Our trusted, proven solutions are known across industries, covering a broad spectrum of dental and medical procedures.

Sybron and Kerr are proud to be a part of the Danaher family of companies. Danaher is a worldwide leader and manufacturer of a broad range of innovative products, technologies, and services.

Please no faxes or phone calls. Only considered candidates will be contacted. Thank you for your interest in Sybron Dental Specialties! We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.