Quality Coordinator- S3

Sandvik; 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

Our client is a leading innovator in the medical device industry, dedicated to developing high-quality, life-enhancing products. We are seeking a highly motivated Senior Quality Assurance Engineer to join our esteemed team in Benoni, Gauteng. This role is pivotal in ensuring that our medical devices meet the highest standards of safety, efficacy, and regulatory compliance.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with relevant regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
• Plan and execute internal and external audits to assess compliance and identify areas for improvement.
• Review and approve product design documentation, validation protocols, and reports to ensure compliance with quality standards.
• Investigate product complaints, non-conformances, and CAPA (Corrective and Preventive Actions) investigations, ensuring timely and effective resolution.
• Participate in risk management activities, including risk analysis and hazard assessments throughout the product lifecycle.
• Develop and deliver quality assurance training to relevant personnel.
• Monitor and analyze quality metrics, identifying trends and recommending process improvements.
• Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality is integrated into all stages of product development and production.
• Stay up-to-date with evolving regulatory requirements and industry best practices in the medical device sector.
• Contribute to supplier qualification and auditing processes.

Requirements

• Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical) or a related scientific field.
• Minimum of 5 years of experience in Quality Assurance within the medical device industry.
• In-depth knowledge of ISO 13485 and FDA 21 CFR Part 820 regulations.
• Proven experience with QMS implementation, auditing, risk management, and CAPA processes.
• Strong understanding of product development lifecycle and design controls.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in quality tools and methodologies (e.g., FMEA, SPC, DOE).
• Strong written and verbal communication skills, with the ability to document processes and findings effectively.
• Ability to work collaboratively with diverse teams and stakeholders.
• Based in or willing to commute to Benoni, Gauteng.

Benefits

• Competitive salary and annual bonus opportunities.
• Comprehensive medical, dental, and vision coverage.
• Generous paid time off and company holidays.
• Opportunities for professional development and career advancement.
• Access to cutting-edge medical technology and research.
• A stimulating and supportive work environment focused on patient safety and product quality.
• Retirement savings plan.
• Employee wellness programs.