Senior QA Engineer - Medical Devices (Remote)

Placements24; Mossel Bay; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Stock options

Remote-first culture

Flexible remote work

Job summary

Placements24 is seeking a Senior Quality Assurance Engineer for a remote-first medical device company. You will lead the Quality Management System in compliance with ISO 13485 and FDA 21 CFR Part 820, conducting internal audits and supporting regulatory inspections.

Remote collaboration with global teams, CAPA management, design control reviews, risk assessment (ISO 14971), and continuous improvement will be central to safeguarding product quality and patient safety.

Qualifications

• 7+ years of experience in Quality Assurance within the medical device industry.
• Proven knowledge of ISO 13485, FDA 21 CFR Part 820, and relevant medical device regulations.
• Experience with QMS implementation, internal auditing, CAPA management, and design controls.
• Strong understanding of ISO 14971 risk management.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other regulations.
• Lead internal audits of manufacturing, R&D, and other areas; support external regulatory inspections.
• Manage CAPA system including investigation, root cause analysis, and verification of effectiveness.
• Review and approve design controls, risk management files, and validation protocols.
• Participate in new product development with QA input and early quality integration.
• Monitor quality metrics and drive continuous improvement initiatives.
• Develop and deliver quality training programs for personnel.
• Manage supplier quality assurance activities and audits.

Skills

Quality Assurance

Regulatory compliance

Documentation

Analytical skills

Remote teamwork

Education

Bachelor's degree in Engineering/Science

Tools

QMS software

CAPA system

Risk analysis tools

Job description

Placements24 is seeking a Senior Quality Assurance Engineer for a remote-first medical device company. You will lead the Quality Management System in compliance with ISO 13485 and FDA 21 CFR Part 820, conducting internal audits and supporting regulatory inspections.

Remote collaboration with global teams, CAPA management, design control reviews, risk assessment (ISO 14971), and continuous improvement will be central to safeguarding product quality and patient safety.