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:
You'll like this role if:
Why You'll Love Working Here:
Who you'll work with:
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:
Technical Skills
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-
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.