Bring more to life.

At Cepheid 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.

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

What you’ll do

In this role, you will:

• 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 process and ensure timely, compliant corrective/preventive actions.

• Manage quality review of service complaints.

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

• 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 6+ 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

• Strong planning, prioritization, and execution skills

• Confident operating in ambiguity and driving clear actions

• Highly collaborative; able to influence without heavy authority

Training responsibilities

• Complete all assigned training on time

• Ensure associates complete required training on time

Travel / vehicle requirements

• Ability to travel as needed

• Valid driver’s license with an acceptable driving record

Rewards & flexibility

This role is eligible for a remote work arrangement. A comprehensive benefits package is offered (details shared during the interview process). This job is also eligible for 10% bonus/incentive pay.

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.