Quality & Compliance Leader, Medical Devices QA/RA

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

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.