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. and covers a broad portfolio of market-leading products across a variety of dental categories.  Competitive starting pay, opportunities for advancement, full benefit package upon hire including medical, dental, vision, 401(k) life & disability insurance and much more!

The Quality Assurance Engineer/Supervisor is responsible for ensuring Quality standards are met or exceeded in all facets of the operation, and will also take a lead role in error cause removal and process improvement. He/she will partner internally in the development and implementation of new or adjusted quality standards, policies, and procedures, as required, and they will provide day-to-day direction to the on-site quality team. The employee will lead the identification, application and implementation of customer focused quality principles and approaches within a highly matrixed transactional environment. He/she will be required to assess processes, identify opportunities for improvement, implement long term permanent corrective actions, develop and deliver new process designs with quality built-in, and deliver clear and concise business cases for process improvement.  

ESSENTIAL DUTIES:

• Ensure compliance with all regulatory, corporate and facility requirements.
• Ensure outstanding Quality System performance via monitoring and measuring of production process performance, and driving any appropriate action, including issuing and follow-up on Corrective/Preventive Actions and Material Review Boards.
• Reviews and monitors Quality metrics and reports trends, to determine if there is a need to escalate issues to the management.
• Utilizing Lean methodology and/or other techniques, take a lead role in identifying process improvement opportunities, prove ROI, and execute proposed change and all necessary change documentation.

• Effectively assess processes, identify opportunities for improvement, quantify impact and translate customer needs into efficient, effective and streamlined processes within our business operations.
• Execute transformational quality initiatives through the application of Value Stream Mapping, Systemic Problem Solving, Statistical Data Analysis and Endto-End Process Improvements including process re-design where applicable.
• Review, Analyze and Report Statistical findings through critical thought and storytelling of key findings and opportunities to all levels within a matrixed organization.
• Interact with stakeholders to share diagnostics, build future state process designs, integrate and build quality error proofing into processes and present implementation recommendations with a balance between short term gains and strategic imperatives.
• Provide leadership on business process improvement and drive forward a culture of continuous improvement and efficiency.
• Partner to identify critical to quality metrics, and support the operationalization of monitoring and management to deliver improved performance across business processes.
• Leverage a broad base of quality engineering tools and problemsolving methodologies to deliver bottom-line impacting and continual process improvements
• Analyze processes, data & systems to identify improvement opportunities and make improvement recommendations.
• Create effective and compelling visual materials/presentations that support the process improvement impact to the organization and adequately represent the impact to quality, cost and time.
• Develop and maintain work plans, time schedules, project task lists, and status reports. Provide direction, guidance, and support to other project team members.
• Define, track, and monitor key success measures associated with projects. Successfully deploy and support change management and appropriate training plans.
• Build and present business cases for Executive Leadership review and approval, including estimates on benefit, effort, resource needs, and timing

• Manage document control functions, including creation, review, and approval of procedures, work instructions and all other documentation for the Quality System.
• Manage the complaint handling system, including trending and review to identify opportunities for improvement.
• Develop, refine, and/or maintain quality standards, policies, and procedures for the facility, including identifying, recommending, and fully implementing changes, in partnership with corporate QRA and local operations teams.

MINIMUM QUALIFICATIONS:

Training and Experience

• Bachelor’s degree in related field of study.

• 5-7 years of relevant experience in a manufacturing environment or equivalent combination of education and experience
  • Previous experience as a lead or supervisor a plus
• Experience in a FDA-regulated environment with a history of identification and implementation of preventative actions.
  • Lean Six Sigma Green Belt certification a plus

Knowledge, Abilities and Skills

• Knowledge of 21 CFR and ISO 13485.
• Proficient in Microsoft Office Suite (Excel, Power Point, Word and Outlook, Project, Statistical Tools)
• Strong attention to detail.
• Excellent leadership skills.
• Ability to work in a team environment as well as alone with little direction.
• Excellent verbal and written communication skills to all levels of the organization.
• Strong organizational, prioritization, and problem solving skills required.

PHYSICAL REQUIREMENTS:
The position requires the ability to sit, stand, stoop, bend, and walk frequently during the shift. The position may require working extended hours or on weekends as needed. Incumbent may need to lift up to 30 lbs. on occasion.

Working Conditions

Office environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.

Travel less than 5%.

Young Dental/Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.