Senior QA Engineer, Medical Devices (Benoni)

Sandvik AB; Gauteng; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, and vision coverage

Paid time off and holidays

Professional development opportunities

Retirement savings plan

Wellness programs

Job summary

Senior Quality Assurance Engineer - Medical Devices in Benoni, Gauteng. This role ensures that medical devices meet safety, efficacy and regulatory standards by building and maintaining the QMS, performing audits, and guiding CAPA processes.

The candidate will collaborate with R&D, Manufacturing and Regulatory Affairs, drive risk management, and deliver QA training while ensuring ongoing conformity with ISO 13485 and FDA requirements.

Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical) or related field.
• Minimum of 5 years of quality assurance experience in the medical device industry.
• Deep knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with QMS implementation, auditing, risk management and CAPA.
• Strong understanding of product development lifecycle and design controls.
• Excellent communication, analytical and problem-solving skills.

Responsibilities

• Develop, implement and maintain the QMS per ISO 13485 and FDA requirements.
• Plan and conduct internal and external audits to assess compliance.
• Review and approve design docs, validation protocols and reports.
• Investigate complaints, non-conformances and CAPA investigations.
• Lead risk management activities including hazard assessments.
• Deliver QA training to relevant personnel.
• Monitor quality metrics and drive process improvements.
• Collaborate with R&D, Manufacturing and Regulatory Affairs.

Skills

Analytical skills

Problem solving

Decision making

Team collaboration

Communication skills

Education

Bachelor's degree in Engineering

Tools

FMEA

SPC

DOE

Job description

Senior Quality Assurance Engineer - Medical Devices in Benoni, Gauteng. This role ensures that medical devices meet safety, efficacy and regulatory standards by building and maintaining the QMS, performing audits, and guiding CAPA processes.

The candidate will collaborate with R&D, Manufacturing and Regulatory Affairs, drive risk management, and deliver QA training while ensuring ongoing conformity with ISO 13485 and FDA requirements.