Manager, Quality Assurance On-Site

Company Summary:

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.

Position Overview:

• Lead and continuously improve the Quality System to ensure Preat’s products are safe, effective, and compliant throughout their lifecycle.
• Play a key role in driving quality excellence, regulatory compliance, and operational performance across the business.

You’ll like this role if:

• You enjoy owning and improving quality systems, not just maintaining them.
• You like working cross-functionally and being a key partner to operations, customer service, and leadership.
• You are energized by solving problems, driving continuous improvement, and making a visible impact.
• You want hands-on exposure across multiple areas of Quality, including audits, CAPA, compliance, and process improvement.

Why You’ll Love Working Here:

• Medium-sized company; not too big, not too small; just enough to make an impact and get things done.
• Your work directly impacts product quality, regulatory compliance, and overall company success.
• Opportunity to take ownership of the Quality System and influence how processes evolve and improve.
• Competitive benefits package including medical, dental, vision, 401k, parental leave, paid holidays, PTO, disability coverage, EAP, and more.

Who you’ll work with:

• This role partners cross-functionally with Operations, Customer Service, Quality & Regulatory Affairs, and leadership across the organization.
• You will work closely with the VP of Quality & Regulatory Affairs, Director of Operations, and Senior Customer Service Manager.

What You’ll Do: 

Quality Systems & Compliance

• Lead and maintain the Quality Management System (QMS), ensuring compliance with internal standards and regulatory requirements (FDA, ISO, etc.).
• Develop and maintain quality plans, including risk assessments, hazard analyses, and control measures.
• Establish and validate quality processes, including product specifications, monitoring, and documentation.

Audits, CAPA & Continuous Improvement

• Conduct internal audits and lead external audits (ISO, FDA, and other regulatory bodies).
• Investigate customer complaints and non-conformances; drive corrective and preventive actions (CAPA).
• Analyze quality data and trends to identify opportunities for improvement and implement solutions.

Cross-Functional Leadership & Support

• Partner with Operations and other teams to improve processes, support product development, and enhance efficiency.
• Train and support employees on quality procedures, policies, and compliance expectations.
• Contribute to strategic initiatives and continuous improvement efforts across the business.

Innovation & Growth

• As part of a smaller, innovative organization, contribute to new processes, evolving technologies, and continuous improvement initiatives.

What You’ll Bring:

• Bachelor’s degree in a science or technical field.
• At least 3 years of Quality Assurance experience in a medical device or pharmaceutical environment.
• Experience supporting or participating in regulatory audits and/or FDA inspections.
• A proactive, hands-on approach with the ability to take ownership and drive results.
  Technical Skills.
• Working knowledge of quality systems, processes, and applicable medical device or pharmaceutical regulations.
• Strong written and verbal communication skills, with the ability to clearly present information and findings, including to leadership.
• Self-starter who can work independently while collaborating effectively across all levels of the organization.
• Strong attention to detail with excellent documentation and record-keeping skills.
• Highly organized with strong planning, coordination, and problem-solving abilities.
• Demonstrated ability to maintain a strong quality focus while balancing multiple priorities.

Compensation Range: $110,000 – $140,000

The pay range reflects the minimum and maximum target for the position at the time of posting. Within the range, the compensation will be determined based on education/training, skill set, experience, and other organizational needs.

Physical Requirements/Working Locations 

Office/Remote Environment

This position is based in an office environment and is primarily sedentary in nature. It requires regular use of standard office equipment, including computers, phones, photocopiers, scanners, filing cabinets, and fax machines. Some roles may involve wearing a headset and sustained computer use for 8 or more hours per day. Employees may be required to sit, stand, or walk for extended periods, and occasional bending, lifting, or carrying items up to 50 pounds may be necessary. Employee may be approved to work one day from home.

Manufacturing/Distribution Environment

This position also operates in a distribution environment. The role routinely involves working around machinery, equipment, and moving mechanical parts. The facility may be subject to varying temperatures, loud noise levels, and airborne particles such as dust or chemical fumes, depending on the area of the plant. This role may require periods of standing, sitting, or walking throughout the workday. Occasional bending, lifting, or carrying items up to 50 pounds may be necessary.

Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, control, or feel; reach with hands and arms and talk. Hearing abilities required for this environment include being able to clearly hear and respond to audible alarms, production equipment, forklifts, and other machinery to maintain a safe work environment. Individuals must be able to distinguish and understand verbal communication including instructions, safety warnings, and team discussions, sometimes in an environment with moderate to high background noise.

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