Senior QA & Regulatory Leader – IVD & ISO 13485

Oy Medix Biochemica Ab; Maryland Heights (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Medix Biochemica is seeking a Senior Manager, Quality Assurance and Regulatory Compliance for the St. Louis site.

You will provide strategic leadership for QA and regulatory compliance, maintain the ISO 13485 QMS, and align with global quality strategy while overseeing FDA and USDA registrations. As a key member of Global Quality, you will partner with Manufacturing, Operations, R&D and Product Management to drive a proactive quality culture and continuous improvement, ensuring product quality

Qualifications

• Degree in life sciences, engineering, quality management or related field.
• Extensive QA / regulatory compliance experience in Biologics, IVD materials or biospecimens.
• Fluent English, strong leadership and communication skills.
• Hands-on experience with ISO 13485 and FDA/USDA requirements.

Responsibilities

• Lead and develop the site QA organization and join Global Quality Team.
• Maintain ISO 13485-based QMS and alignment with global quality strategy.
• Oversee FDA/USDA registrations, audits and inspections.
• Provide QA oversight for product release, validation, and documentation.
• Coordinate internal and supplier audits and ensure regulatory compliance.
• Promote lean culture and continuous improvement in manufacturing.
• Collaborate closely with Manufacturing, Operations, and R&D.

Skills

Quality leadership

Audits & CAPA

Lean 5S/6S

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s or Master’s in life sciences / engineering / quality management

Tools

Quality management software

Job description

Medix Biochemica is seeking a Senior Manager, Quality Assurance and Regulatory Compliance for the St. Louis site.

You will provide strategic leadership for QA and regulatory compliance, maintain the ISO 13485 QMS, and align with global quality strategy while overseeing FDA and USDA registrations. As a key member of Global Quality, you will partner with Manufacturing, Operations, R&D and Product Management to drive a proactive quality culture and continuous improvement, ensuring product quality