Senior Quality Assurance Engineer - Medical Devices

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

About the Role

Our client, a pioneering company in the medical device sector, is seeking an experienced Senior Quality Assurance Engineer to join their expanding, remote-first team. This is a critical role focused on ensuring the highest standards of quality and regulatory compliance for our innovative medical products. You will be instrumental in developing, implementing, and maintaining quality systems, conducting internal audits, and supporting external regulatory inspections. The ideal candidate possesses a deep understanding of quality assurance principles within the medical device industry, including ISO 13485 and FDA regulations. This fully remote position requires exceptional analytical skills, meticulous attention to detail, and the ability to work autonomously and collaboratively with global teams. You will play a pivotal role in safeguarding product quality and patient safety, contributing directly to the company's mission of improving healthcare outcomes. The role demands proactive engagement and a commitment to excellence.

Key Responsibilities

Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations. Lead and conduct internal audits of manufacturing processes, R&D, and other functional areas to ensure compliance. Support external audits and inspections by regulatory bodies (e.g., FDA, Notified Bodies). Manage the CAPA (Corrective and Preventive Action) system, including investigation, root cause analysis, and verification of effectiveness. Review and approve design control documentation, risk management files, and validation protocols. Participate in new product development teams, providing QA input and ensuring quality considerations are integrated early. Monitor and analyze quality metrics, identifying trends and implementing continuous improvement initiatives. Develop and deliver quality training programs to relevant personnel. Manage supplier quality assurance activities, including audits and qualification of critical suppliers.

Requirements

Bachelor's degree in Engineering, Science, or a related field. Advanced degree is a plus. Minimum of 7 years of experience in Quality Assurance within the medical device industry. In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations. Proven experience with QMS implementation, internal auditing, CAPA management, and design controls. Strong understanding of risk management principles (ISO 14971). Excellent analytical, problem-solving, and documentation skills. Exceptional communication and interpersonal skills, with the ability to work effectively in a remote, global team environment. Proficiency in quality tools and statistical analysis software. Ability to manage multiple projects and priorities independently.

Benefits

Our client offers a highly competitive salary, comprehensive health, dental, and vision insurance, stock options, and a flexible remote work environment. We provide significant opportunities for professional development, career advancement, and the chance to work on cutting-edge medical technologies. You will join a collaborative and mission-driven team dedicated to making a difference in patient lives. As a remote-first organization, we are committed to supporting our employees' well-being and work-life balance. Be part of a company where your expertise in quality assurance is valued and crucial to success.