Quality Systems Leader: Own the QMS & Compliance

Young Innovations; Earth City (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Parental leave

Paid holidays

PTO

Disability coverage

Employee assistance program (EAP)

Job summary

Young Innovations is seeking a seasoned QA/RA leader to manage and improve the Quality Management System, ensuring FDA, ISO, and other regulatory compliance across the product lifecycle.

You will lead audits, CAPA, and continuous improvement initiatives while collaborating with Operations, Customer Service, and senior leadership to deliver high-quality medical devices and pharmaceuticals.

Qualifications

• Experience leading QA/RA programs and regulatory compliance.
• Proven ability to manage internal and external audits.
• Strong cross‑functional collaboration with operations, customer service, and leadership.
• Lead CAPA, quality metrics, and continuous improvement initiatives.
• Ability to mentor and develop quality professionals.

Responsibilities

• Establish and maintain the quality management system to meet FDA, ISO, and regulatory requirements.
• Coordinate audits and inspections, and lead responses and CAPA actions.
• Develop and implement training programs for quality assurance and compliance.
• Drive cross-functional quality improvements across product lifecycle.

Skills

Quality system leadership

Regulatory compliance

Audit management

CAPA & improvements

Cross-functional collaboration

Training & mentoring

Job description

Young Innovations is seeking a seasoned QA/RA leader to manage and improve the Quality Management System, ensuring FDA, ISO, and other regulatory compliance across the product lifecycle.

You will lead audits, CAPA, and continuous improvement initiatives while collaborating with Operations, Customer Service, and senior leadership to deliver high-quality medical devices and pharmaceuticals.