Senior Quality Assurance Specialist

About the role

Watchmaker Genomics is seeking a Senior Quality Assurance Specialist to join its Cape Town team. You will lead and improve core Quality Management System (QMS) processes in an ISO 13485‑compliant environment, ensuring high‑quality delivery of DNA‑ and RNA‑modifying enzymes worldwide.

Key responsibilities

• Act as QA lead on complex, cross‑functional quality system activities.
• Own and continuously improve QMS processes such as CAPA, non‑conformance (NC) and change control.
• Lead investigations, perform root‑cause analysis and implement corrective actions.
• Review and approve complex quality records, batch records, certificates of analysis and change controls.
• Support production quality across manufacturing, QC testing and supply‑chain operations.
• Plan and execute internal, supplier and external audits, ensuring audit readiness.
• Investigate customer complaints and drive appropriate resolutions.
• Review calibration, validation and qualification documentation for compliance.
• Analyse QMS metrics and contribute to management review and continuous‑improvement initiatives.

Required profile

• Minimum 8 years experience in a quality environment (ISO 13485 and/or cGMP).
• Degree in biochemistry, molecular biology or a related discipline; MSc or higher preferred.
• Proven ability to lead QA activities, make independent decisions and mentor junior staff.

Required skills

• ISO 13485 compliance
• cGMP knowledge
• CAPA management
• Non‑conformance handling
• Change control processes
• Root‑cause analysis
• Audit planning and execution
• QMS metrics analysis
• Calibration, validation and qualification documentation review

What we offer

• Opportunity to work in a fast‑growing early‑stage life‑science company.
• Collaboration with international teams in Cape Town and Boulder.
• Access to cutting‑edge genomics technologies.