Senior Quality Assurance Engineer - Medical Devices

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

Benefits offered by this job

Competitive salary

Medical coverage

Bonuses

Career development

Retirement savings plan

Wellness programs

Job summary

Placements24 is seeking a Senior Quality Assurance Engineer for our Benoni, Gauteng facility to ensure medical devices meet safety, efficacy, and regulatory standards. You will build and maintain QMS, conduct audits, lead CAPA investigations, and collaborate with R&D, manufacturing, and regulatory affairs to drive continuous improvement across the product lifecycle.

Qualifications

• Bachelor's degree in Engineering or related scientific field.
• Minimum 5 years of QA experience in medical devices.
• Deep knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with QMS implementation, auditing, risk management, and CAPA.
• Strong written and verbal communication skills and cross-functional collaboration.

Responsibilities

• Develop, implement, and maintain QMS per ISO 13485 and FDA 21 CFR Part 820.
• Plan and conduct internal and external audits.
• Review design documentation, validation protocols, and reports for compliance.
• Investigate product complaints, non-conformances, and CAPA investigations.
• Participate in risk management across the product lifecycle.
• Deliver quality assurance training to personnel.
• Monitor quality metrics and drive process improvements.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality across development and production.
• Stay up-to-date with evolving regulatory requirements and best practices.
• Contribute to supplier qualification and auditing processes.

Skills

Analytical thinking

Problem solving

Decision making

Education

Bachelor's degree in Engineering

Tools

FMEA

SPC

DOE

Job description

About the Role

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. You will be instrumental in establishing and maintaining robust quality management systems, conducting audits, and driving continuous improvement throughout the product lifecycle. This position offers an exciting opportunity to contribute to a company making a real difference in healthcare, based in our **Benoni, Gauteng** facility.

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.