Quality Manager

Young Innovations • Bridgeton, MO

1d • $110,000 - $140,000 • Onsite

About The Position

Under the direction of the VP of Quality & Regulatory Affairs, the Quality Manager leads the quality system to ensure it meets applicable regulatory requirements. The role administers Quality Assurance, process improvement initiatives, product design verification activities, and distribution quality to ensure products meet customer needs and expectations.

The Quality Manager leads and develops the QA team, partners across Operations, Customer Service, Quality & Regulatory Affairs, and organizational leadership, and drives quality and compliance throughout the product lifecycle. The position oversees audits, inspections, CAPA and customer complaints, management reviews, quality metrics, process controls, and continuous improvement. It also supports product development, regulatory submissions, international registrations, and market release activities.

This role is based in a manufacturing and distribution environment and routinely involves working around machinery, equipment, and moving mechanical parts. Conditions may include varying temperatures, loud noise, and airborne dust or chemical fumes. The position may involve standing, sitting, walking, occasional bending, and lifting or carrying items up to 50 pounds.

Requirements

• Bachelor of Science degree in a related field.
• At least seven years of relevant experience, including five years in a management or supervisor role in the medical device and pharmaceutical industries.
• Prior experience participating in and/or leading FDA audits.
• In-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, and industrial microbiology.
• Strong knowledge of Lean Manufacturing disciplines and continuous improvement.
• Ability to supervise a staff of quality employees.
• Ability to communicate effectively, verbally and in writing.
• Ability to work cross-functionally and influence individuals outside the direct chain of command.
• Excellent analytical and interpersonal skills.
• Strong skills applying statistical methodologies and problem-solving techniques.
• Strong problem-solving skills.
• Proactive, hands-on approach with the ability to take ownership and drive results.

Responsibilities

• Establish strategies to maintain compliance with regulators, including the FDA, DEA, NAP, and Boards of Pharmacy.
• Coordinate functions to identify, manage, and mitigate compliance risks across the product lifecycle.
• Maintain the quality management system, conduct regular audits, provide employee training, and ensure compliance with changing requirements.
• Provide direct and strategic oversight of Quality Assurance for the manufacturing and distribution of medical devices and pharmaceuticals.
• Monitor evolving regulations, guidelines, and trends that may affect the company and the effectiveness of its QMS.
• Lead, mentor, and develop the QA team, and provide quality-related leadership and technical expertise to other departments.
• Work with sales, engineering, manufacturing, regulatory affairs, and other departments to ensure quality throughout the product lifecycle.
• Foster an organizational culture of quality through training, communication, and leadership.
• Address significant events requiring decision-making, collaboration, and communication across organizational levels.
• As needed, serve as the site's Management Representative during agency investigations, audits, and inspections, and prepare required responses and corrective action reports.
• Manage internal audit programs and coordinate external government audits and inspections, including closure of observations.
• Initiate and implement quality improvement activities and educate and train employees on the Quality Management System.
• Establish and implement metrics, including process capability, control charts, and measurement quality, to monitor system effectiveness and support product quality decisions.
• Conduct Management Reviews in compliance with ISO and FDA requirements.
• Manage and maintain compliance with FDA Quality System Requirements.
• Assist Regulatory Affairs and Operations with product development, regulatory submissions, and technical information for international registrations.
• Support product market release, including review of labeling, promotional materials, product and manufacturing-process changes, and related Quality System documentation changes.
• Manage the Customer Complaint program and ensure timely, effective investigations and corrective actions.
• Coordinate quality control resources for problem identification, resolution, loss reporting, and continuous improvement.
• Support engineering product development projects by 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.
• Work with supplier and customer quality representatives on quality-control problems and ensure effective corrective action.
• Oversee the onsite laboratory, documentation system, and associated requirements.

Benefits

• Competitive benefits package including medical, dental, and vision coverage, 401(k), parental leave, paid holidays, PTO, disability coverage, and an Employee Assistance Program (EAP).
• Additional benefits are described as available.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager