Quality Management System Specialist

Our Johnson City, TN Location is looking for someone to join our team as a Quality Management System Specialist.

We offer competitive wages and a full menu of benefits including health (3 options), dental (provided), vision, life (provided) + extra life, short-term and long-term disability (provided), 401k (retirement) with company matching, 10 holidays and paid time off.

SCOPE

This position is responsible for administration and management of the QMS systems and manages Infinity software for operations for electronic DHR management.   This position assists with regulatory review/submissions in supporting the release of new or modified products, modified labeling, marketing, and documentation materials. This position assists documentation in change control management, establishes registrations, device listings and annual reports. Acts as the regulatory liaison between DENTSPLY Sirona divisions to support international product registrations, supports product technical files as necessary, assists in creating supplier agreements, perform supplier audits and also assist with internal audit preparations. 

KEY RESPONSIBILITIES

• Assists in the implementation of international and domestic regulatory strategies.
• Manages shipping restrictions in AX and GUDID database for FDA website.
• Assists in the preparation, coordination, and compiling of:
  • Product applications to foreign and domestic regulatory agencies to include but not limited to 510(k)s, PMAs, Canadian licensing and technical files and design dossiers and
  • Labeling, marketing, internet and advertisements to assure compliance with applicable regulatory and corporate requirements.
• Assists in the review and approval of documentation to be included with regulatory filings, including but not limited to internet content, labeling content, DFU content and other associated marketing documentation.
• Interacts with various departments/individuals to monitor individual CAPA progress and ensure implementation/effectiveness criteria has been met when associated with regulatory, labeling or documentation activities.
• Supports Senior QA/RA Manager during inspections/audits by the FDA, notified bodies, corporate audits, or other international regulatory bodies.
• The QA Specialist acts also as official correspondent for FDA and is responsible for being the main contact for the company’s device registration and product listing with FDA, managing all related communications, updates, and submissions through the FDA’s FURLS system.
• They are responsible for creating, updating, and canceling registrations and listings, providing FDA with necessary company information, and ensuring the accuracy and completeness of the FDA's records.
• Supports the Senior QARC Manager during market actions as required.
• Supports Purchasing in the creation of supplier quality agreements.
• Supports Marketing in the timely review of labeling and other marketing materials.
• Interacts with New Product Development to create and update product technical files as required.
• Interacts with other Dentsply Sirona divisions as required to obtain/supply required technical information.
• Supports product changes in accordance with regulatory guidelines.
• Manages and reports changes in the Change Control system.
• Identify potential problems and provide guidance to document authors or team members as appropriate.
• Perform internal audits and participate in interdivisional audits.
• Participate in teams that handle problem reports, corrective action, trending and preventive actions.
• Develop and maintain current regulatory knowledge.
• Manage Infinity for electronic DHRs.
• Manages electronic QMS and LMS for the location.
• Depending on the needs of the company, the employee may be entrusted with and asked to perform other tasks related to his/her competence.

EDUCATION

Bachelor’s degree from an accredited college or university preferred; or, two to four years related experience and/or training; or, equivalent combination of education and experience.

YEARS AND TYPE OF EXPERIENCE

• Two to four years related experience and/or training; or equivalent combination of education and experience.
• Prefer 2-3 years handling a regulated activity (complaints, CAPA investigations, or regulatory affairs) in an FDA regulated industry.

KEY SKILLS, KNOWLEDGE & CAPABILITIES

• Working knowledge of FDA/ISO 13485 and ISO 9001 standards and procedures especially as they apply to filings, labeling and documentation.
• Willingness and ability to research issues and provide prompt follow-up.
• Excellent organizational, teamwork and interpersonal skills.
• Ability to work well in a multi-disciplined environment.
• Ability to be attentive to detail.
• Ability to work effectively on multiple projects.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
• Ability to effectively present information to top management.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Proficient in MS Office products, to include but not limited to, Word and Excel, as well as internet and email systems.