|Job Location:||Earth City, MO|
Young Dental is a leading designer, manufacturer, and marketer of consumables, instruments, and other items used in the dental industry. The products we create begin as a bright idea either from within our organization, backed by extensive research and development, or are generated by clinical professionals worldwide. Every product we manufacture is subject to strict quality control measures before being made available to a dental office. The result is a high-quality product that provides clinical benefits to the patient while providing efficacy, reliability, and comfort to the dental professional. Young Dental is a wholly owned subsidiary of Young Innovations, Inc., whose sales exceeds $140 million and covers a broad portfolio of market-leading products across a variety of dental categories.
CHARACTERISTICS OF THE CLASS: Under general direction, supports the quality system to ensure it meets all regulatory requirements. Through administration of Quality Assurance & Control activities, process improvement initiatives and product design verification activities, assures that products sold meet the needs and expectations of customers. Performs related duties as required.
Manages and maintains compliance with FDA Quality System Requirements, including company registration, new product submissions, and management of CAPA system. Assists with the development of product submissions for FDA and other major market regulatory agencies.
Conducts internal audits and coordinates and manage external ISO audit schedules, correspondence and closing of findings. Ensures compliance of labeling and advertising.
Participates as Company representative during agency investigations, audits, and inspections and prepares required responses and corrective action reports when necessary. Leads and trains the internal audit team to maintain compliance with stated quality policies and procedures.
Provides support to market-released products as necessary, including review of labeling, promotional materials, product/manufacturing process changes and related Quality System documentation changes requiring government approval.
Assists with maintenance of Regulatory Affairs product files to support compliance with regulatory requirements. Audits Design history files for new products for FDA compliance, if needed. Manages sterilization records and facilitation with contract sterilizer and 3rd party validation processes.
Evaluates field reports, complaints, product returns and product analysis results to determine Medical Device Reporting (MDR) eligibility. Executes follow-up/investigation to assure all required elements are available for MDR review
Performs process validation and verification. Ensure that any process change that requires regulatory approval is identified and submitted to the proper regulatory authorities.
RELATED DUTIES: Prepares all reports for management as requested.
Training and Experience. A Bachelor of Science degree in a related field, supplemented by at least seven years of relevant experience with 5 years in leadership role in a chemical manufacturing environment with demonstrated pattern of success. Prior experience participating and/or leading FDA audits.
Knowledge, Abilities and Skills
In depth knowledge of 21 CFR 210, 211, and 820. Specific knowledge of non-sterile OTC or Rx liquids. Understanding of classified manufacturing areas (i.e., Class 10,000 per Fed STD 209E or ISO Class 7). Understanding of flow control, contamination control, industrial microbiology. Thorough knowledge of Good Manufacturing Practices. Strong knowledge of relevant regulatory guidance, including pharmaceutical current Good Manufacturing Practices (cGMPs), FDA, EPA and ISO. Strong knowledge of Lean Manufacturing disciplines and continuous improvements.
Ability to supervise a staff of quality and regulatory employees. Ability to communicate effectively, both verbally and in writing. Ability to read and understand published regulations. Ability to work effectively cross-functionally, influencing other key individuals outside of direct chain of command.
Excellent analytical and interpersonal skills. Strong skills in applying statistical methodologies and problem-solving techniques. Skill in writing and editing technical documentation. Strong problem solving skills.
Must be able to stand for long periods of time occasionally.
Office and manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
Minimal travel required.