Position Title: Reports To
Manager, Quality Systems / Regulatory Affairs Vice President / General Manager
Date Reviewed Department
3/28/2005 Quality Systems / Regulatory Affairs
Salary Grade: 28
• Assume a leadership role with authority for the development, implementation, evaluation, and
maintenance of a comprehensive and effective quality and regulatory program that complies
with FDA regulations, ISO requirements, Corporate Regulatory Compliance and other
applicable regulatory bodies or standards.
• Responsible for all aspects of coaching, mentoring, managing and supervising the activities and
personnel of the Quality Assurance/Regulatory Affairs Department.
• Responsible for directly supervising the quality assurance personnel. This includes training;
assigning, prioritizing and monitoring work duties; and providing performance and
• Directly and frequently communicates and interacts with all departments including
manufacturing, R&D and sales/marketing and other Dentsply Divisions, including Friadent
Germany and Dentsply Corporate Compliance with regards to quality or regulatory issues.
• Develops and manages departmental budget and Departmental resources.
• Directly and frequently communicates and interacts with other DENTSPLY sister divisions.
• Plan future needs and accommodate expansion of the Quality Assurance Department.
• Provide reports to the president and management staff on the status of quality programs and
• Leads the management staff in addressing quality issues.
• Acts as management representative for Regulatory bodies.
• Perform other duties at the direction of the General Manager.
• Direct and when necessary, perform inspections of raw materials, in-process materials, labeling
and finished goods.
• Direct and when necessary, perform analytical quality control tests and interpret the results
(i.e., x-ray diffraction)
• Direct and when necessary, perform internal audits of processes, facilities and documentation to
assure compliance with internal procedures and FDA/ISO regulations and requirements.
• Direct and when necessary, perform audits of component vendors and contract manufacturers
and service suppliers to assure quality materials and services are provided that meet Friadent
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• Perform and evaluate sterilization validations (EtO, Gamma) according to published standard
methods, as well as playing a key role in all other validation efforts.
• Oversee the documentation and evaluation of customer complaints, and direct corrective
actions as necessary, as well as reporting serious complaint and MDR information to the
Corporate Complaint Officer.
• Oversees and assures the smooth operation of the CAPA System.
• Write and implement procedures and specifications detailing every aspect of an effective
quality system that complies with FDA, ISO, Corporate Regulatory Compliance and other
applicable regulations and requirements.
• Maintain and control all documentation involved in the quality system (i.e., Device Master
Records, Device History Records, CAPA system records, complaint system records, etc.).
Oversee Document Control.
• Responsible for assisting with the review of Consultant(s) prepared IDE’s, 510(k)’s, PMA’s,
etc. and assuring the submissions are submitted and tracked with the FDA or other regulatory
bodies on a timely basis.
• Oversees FDA inspections, ISO Assessments and customer audits.
• Acts as liaison between CeraMed, the FDA, and other regulatory bodies with regards to quality
or regulatory issues.
Knowledge, Skills & Abilities
• Minimum of 5 years experience with FDA Class III devices, including experience with FDA
inspections and responses
• Proven Leadership ability and 10 years experience managing direct reports
• 10 years experience within a manufacturing environment with direct quality system working
• 10 years budget preparation/administration experience.
• Ability to read and write English Language
• Strong decision-making skills
• Excellent communication skills – both written and oral
• Ability to multi-task
• Ability to work as a team player
• Ability to follow written guidelines
• Mathematical ability
• Ability to work independently, plan and prioritize
• Ability to be flexible/adapt as daily schedule may change rapidly
• Computer proficiency with standard software programs
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Education Or Formal Training
• Bachelors Degree in science based or other appropriate curriculum
• 3-5 years extensive and applicable experience in a regulated medical products or equivalent
• Training in FDA and ISO Quality System regulations and standards and associated documents
such as Risk Management.
Material And Equipment Directly Used
• Various analytical instruments
• Personal computer, copier, printer.
• Telephone, Fax
Note: This job description is not intended to be an exhaustive list of all duties,
responsibilities, or qualifications associated with the job.
Department Manager Approval: Date:
Human Resources Approval: Date:
Employee signature below signifies understanding and agreement with the requirements and
responsibilities outlined in this job description.
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