|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.
- Reviews document change requests, document change controls, investigations, non-conformances, work orders/BOM, protocols, reports, batch records, and other GMP documents in a timely manner.
- Leads the CAPA review board, the CAPA process and makes recommendations for corrective actions
- Assure compliance with regulatory requirements and internal company procedures by planning, conducting, reporting quality inspections; internal and external facility evaluations, system audits, and data reviews that support company product releases.
- Draft, review, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications
- Track and trend planned and unplanned deviations, complaints, and corrective actions
- Reviews and approves ingredients/materials for use in commercial production.
- Assist management in federal, state, local and external registrar audits/inspections.
- Assists in development of QA statistical analysis/reports and plans, and documentation
- Performs statistical analysis for non-conformities
- Perform trending analysis related to quality systems and generate associated reports for quality and site management as required
- Assists in the development and implementation of design of experiments and serves on problem solving teams.
- Drive continuous improvement of site quality systems. Performs gap assessments with quality systems and drug/device master files ensure compliance
- Coordinate and perform the drafting of Quality Agreements with suppliers of materials/services and with customers. Will also ensure commitments within approved quality agreements are met.
- Participate on cross-functional teams to facilitate new product launches in domestic and international markets.
- Other duties as assigned.
- Experience in handling CAPA, Non-conforming material and Change controls
- Knowledge of regulatory standards, including but not limited to 21 CFR 820; 21 CFR 210/211; ISO 13485, ISO 14971, CMDR, MDD and JPAL.
- Exposure regulatory agency such as FDA is an added advantage
Regularly interfaces with:
Entire Earth City Staff; YI Staff, External Licensing Vendors; Federal, State and Other Government Compliance Officials
- Bachelor’s Degree in life science, engineering or related field
- 3-5 years Quality Assurance experience in Medical Device or Pharmaceutical Industry. Experience in Regulatory will be considered.
- Strong attention to detail
- Able to work in a team environment
- Strong communication skills, both written and verbal