Senior Manager, Quality Assurance and Regulatory Compliance

Job overview

The Senior Manager, Quality Assurance and Regulatory Compliance is an onsite role in Maryland Heights, MO. Compensation is not specified. The position supports Medix Biochemica’s St. Louis site and its global quality strategy for in vitro diagnostics materials.

What you'll do

• Lead and develop the site Quality Assurance organization
• maintain and continuously improve the ISO 13485-based Quality Management System
• act as local Quality Management Representative
• manage applicable USDA and FDA registrations
• oversee product release, manufacturing documentation, validation, qualification, product development, and design transfer
• coordinate audits and inspections
• support regulatory compliance and continuous improvement in partnership with manufacturing and other functions.

What we're looking for

Skills & competencies

senior manager

quality assurance

regulatory compliance

iso 13485

fda

usda

maryland heights mo

medix biochemica

quality management system

audits

capa

manufacturing partnership

Work arrangement

• Weekend coverage required

Why this role

Site leadership role on the Global Quality team; responsibility for ISO 13485 QMS and applicable FDA and USDA compliance; supports a company supplying mission-critical in vitro diagnostics raw materials.

About the employer

Medix Biochemica is hiring for this role. Industry: All Other Miscellaneous Chemical Product and Preparation Manufacturing. Sector: 32.