Quality Manager

Young-Innovations; Earth City (MO); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Parental leave

Paid holidays

PTO

Disability coverage

EAP

Job summary

Young Innovations, Inc. is seeking a QA/RA leader to manage the quality system and ensure regulatory compliance for medical devices and pharmaceuticals.

You will partner with Operations, Customer Service, and leadership to drive CAPA, audits, and continuous improvement across the product lifecycle. The ideal candidate has a BS degree in a related field with 7+ years in quality roles, including 5+ years in management, and extensive FDA regulatory experience.

Qualifications

• BS degree in a related field with 7+ years of relevant experience in medical devices/pharma
• At least 5 years in a management or supervisor role
• Experience participating in FDA audits
• Hands-on, proactive approach with ownership and drive
• Strong cross-functional communication and leadership abilities

Responsibilities

• Lead and manage QA/RA quality system to meet regulatory requirements
• Coordinate audits, CAPA, and process improvements across functions
• Provide strategic QA oversight for manufacturing and distribution of medical devices and pharmaceuticals
• Lead QA team development and cross-department collaboration on quality matters
• Serve as Management Representative during agency investigations and inspections

Skills

Quality management

FDA audits

Lean manufacturing

Statistical methods

Cross-functional leadership

Education

Bachelor of Science in related field

Job description

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 HealthWe 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:Under direction from the VP of QA/RA, lead management of the quality system to ensure it meets applicable regulatory requirements.Through administration of Quality Assurance, process improvement initiatives and product design verification activities and distribution to ensure that products sold meet the needs and expectations of customers.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, Plant Manager, and Production Manager.What You’ll Do:Establish strategies to maintain compliance with Regulators such FDA, DEA, NAP, and Board of Pharmacies. Coordinate different functions to proactively identify, manage, and mitigate compliance risks across the entire product lifecycle.Maintain a strong quality management system, implement regular audits, provide ongoing employee training, and ensure ongoing compliance with changing regulatory requirements.Provide direct and strategic surveillance of the Quality Assurance team for the manufacturing and distribution of medical devices and pharmaceuticals.Ensure effectiveness of the QMS by staying updated on evolving regulations, guidelines, and trends that may impact the company.Lead the Quality Teams:Lead and manage a QA team by building, mentoring, and developing quality professionals.Provide leadership and technical expertise to the QA team and other departments on quality-related matters.Work with other departments, such as sales, engineering, manufacturing, and regulatory affairs, to ensure quality throughout the product lifecycle.Foster a culture of quality throughout the organization through training, communication, and leadership.Address raising events that require decision making, collaboration, and communication with different levels of the organization.As necessary, serve as the site’s Management Representative during agency investigations, audits, and inspections and prepares required responses and corrective action reports. Manage the internal audit programs and coordinates external audits and inspections from government agencies, including closing observations.Initiate and implement quality improvement activities as appropriate to raise the quality and compliance of the site’s product line and processes, which includes educating and training employees on the Quality Management System.Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions. Conduct Management Review in compliance to ISO and FDA requirements.Manage and maintains compliance with FDA Quality System Requirements. Assist regulatory Affairs and Operations with product development, regulatory submissions and technical information for international registrations.Support the market-release of products as necessary, including review of labeling, promotional materials, product/manufacturing process changes and related Quality System documentation changes.Manage the Customer Complaint program and ensure investigations and corrective actions are timely and effectively implemented.Serve as the Coordinator of the quality control resources for problem identification, resolution, loss reporting and continuous improvements.Support engineering efforts by participating in product development projects, representing quality assurance and the customer.Design, implement and document procedures for process control, process improvement, testing and inspection. Perform root-cause analysis and other problem solving activities to identify and implement effective corrective actions and process improvements.Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.Oversee onsite laboratory, documentation system and associated requirements.What You’ll Bring:Bachelor of Science degree in a related field, supplemented by at least seven years of relevant experience with 5 years in a Management or Supervisor role in the medical devices and pharmaceutical industries.Prior experience participating and/or leading FDA audits.A proactive, hands-on approach with the ability to take ownership and drive results.Technical SkillsIn depth knowledge of 21 CFR 210, 211, and 820.Strong knowledge of relevant regulatory guidance, including pharmaceutical current Good Manufacturing Practices (cGMPs), FDA, EPA and ISO.Understanding of flow control, contamination control, industrial microbiology.Strong knowledge of Lean Manufacturing disciplines and continuous improvements.Ability to supervise a staff of quality employees. Ability to communicate effectively, both verbally and in writing.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.Strong problem solving skills.Compensation Range: $110,000 - $140,000The 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-Manufacturing/Distribution EnvironmentThis 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.