QA & Regulatory Lead - Medical Device Quality & CAPA

People Dimension; Centurion; Sur place; ZAR 253 890 - 304 110; Plein temps

Résumé du poste

People Dimension in Centurion seeks a Quality Management professional responsible for ensuring the effective closure of CAPAs, nonconformances, and customer complaints. The ideal candidate has a technical engineering background and a strong understanding of quality systems, with a focus on compliance with ISO 13485.

The role includes drafting validation protocols, facilitating audits, and coaching staff. A tertiary degree in engineering or natural sciences, along with a minimum of 2 years of experience, is required for this position.

Qualifications

• Minimum of 2 years experience in quality management.
• Strong writing skills essential for documentation.
• Technical/mechanical engineering background preferred.

Responsabilités

• Ensure closure of CAPAs, nonconformances and customer complaints.
• Draft and approve manufacturing and validation protocols.
• Provide technical QA oversight for implantable medical devices.
• Coach staff on quality systems and regulatory requirements.
• Facilitate internal and supplier audits.

Connaissances

Good communication skills

High ethical standards

Good understanding of statistics

Computer literate: Microsoft Office

Formation

Tertiary degree in engineering discipline or natural sciences

Description du poste

People Dimension in Centurion seeks a Quality Management professional responsible for ensuring the effective closure of CAPAs, nonconformances, and customer complaints. The ideal candidate has a technical engineering background and a strong understanding of quality systems, with a focus on compliance with ISO 13485.

The role includes drafting validation protocols, facilitating audits, and coaching staff. A tertiary degree in engineering or natural sciences, along with a minimum of 2 years of experience, is required for this position.