Senior Commercial Quality Assurance Specialist - Healthcare

At Radiometer COE QRA (a Danaher operating company), our work helps clinicians make faster, more confident decisions that improve patient outcomes. You’ll join a team that values belonging, ownership, and continuous improvement — where your perspective matters, and where the Danaher Business System (DBS) turns ideas into measurable impact.

For more than 90 years, our diagnostics have helped elevate the lab’s role in care delivery — from routine testing to complex investigations. Across hospitals, reference labs, research settings, and physician offices worldwide, Cepheid solutions support reliable results when time and accuracy matter most.

The role:

We’re hiring a Senior Commercial Quality Assurance Specialist to lead and strengthen our Quality System processes and related deliverables, ensuring ongoing compliance with corporate quality policies and applicable regulatory requirements. You’ll partner closely with process owners, CAPA stakeholders, internal auditors, and leaders — not just to “check compliance,” but to teach, guide, improve, and keep the system working in real life. Become part of a dynamic Commercial quality and Regulatory Assurance Team , where you will contribute to quality excellence, regulatory assurance and business success across Danaher Diagnostics Operations throughout the Africa region.

This role reports to the Senior Manager, Commercial Quality & Regulatory Affairs and sits within the QRA Department. The position is based in Johannesburg, South Africa .

What you’ll do

In this role, you will:

• Coordinate the implementation and ongoing maintenance of the ISO 13485:2016 Quality Management System

• Ensure all QMS processes, procedures, work instructions, and records are established, maintained, and controlled in accordance with ISO 13485 requirements.

• Drive Quality System and Regulatory Compliance processes to sustain continuous compliance with corporate policies and applicable regulations.

• Deploy and maintain global QMS policies/procedures locally, with strong ownership and independence.

• Monitor and report QS deliverables through global key indicators and local Visual Daily Management.

• Plan and conduct Quality System Management Reviews for the site.

• Act as the Site Quality Management Representative.

• Build quality plans as needed and ensure deliverables land on time.

• Control and approve local QMS document changes to maintain compliance with ISO/QSR requirements.

• Establish and manage the internal audit program (annual plan, auditor coordination, execution, and follow-up).

• Own the CAPA and Non-conformance process and ensure timely, compliant corrective/preventive actions.

• Manage quality review of service complaints.

• Support continuous improvement initiatives across departments (DBS mindset).

• Implement, maintain ISO 13485 certification compliance and audit readiness.

• Manage quality aspects of suppliers/service providers impacting the QMS (quality agreements, 3PL, channel partners).

• Train and coach teams on quality techniques, expectations, and practical compliance.

• Serve as the designated person for vigilance and reporting (FSCA/reportable incidents) to relevant authorities when required.

• Support Commercial and Global Access teams with quality documentation for tenders.

What you bring (essential requirements)

Education / Experience

• Bachelor’s degree with 5+ years related experience, or

• Master’s degree with 4+ years related experience, or

• Doctoral degree with 3+ years related experience

Knowledge & Skills

• Excellent written and verbal English communication

• Strong working knowledge of ISO 13485

• Strong working knowledge of US QSR requirements

• Familiarity with local regulations (South Africa / broader Africa) is a plus

• 3-5 years' experience in the Quality Field

• Strong planning, prioritization, and execution skills

• Confident operating in ambiguity and driving clear actions

• Highly collaborative; able to influence without heavy authority

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.