Remote Quality Control Specialist - Medical Devices

Placements24; Polokwane; Hybrid; ZAR 360,000 - 540,000; Full time

Benefits offered by this job

Remote work

Health benefits

Professional development

Retirement plan

Bonuses

IT equipment

Job summary

Placements24 is seeking a Remote Quality Control Specialist to ensure medical devices meet ISO 13485 and regulatory standards. This fully remote SA role requires attention to detail and strong analytical skills.

You will document testing activities, manage QC data, and support audits while collaborating with R&D, manufacturing and regulatory teams. A bachelor’s in science/engineering and 3–5 years QA experience are preferred.

Qualifications

• Bachelor's degree in Science, Engineering, or related field.
• 3–5 years of quality control/quality assurance experience.
• Strong understanding of ISO 13485 quality management systems.
• Familiarity with GMP and GDP practices.
• Proficiency with precision measuring instruments and testing equipment.
• Ability to work remotely with minimal supervision.
• Experience with electronic QMS software is advantageous.

Responsibilities

• Perform QC inspections and tests on incoming materials, in-process components, and finished devices per procedures.
• Document inspection and testing activities with detailed records in the QMS.
• Identify and report non-conformances; support corrective actions.
• Analyze quality data to identify trends and risks for process improvement.
• Ensure compliance with ISO 13485, GMP, GDP and regulatory guidelines.
• Participate in audits and provide required documentation and support.
• Maintain and calibrate QC equipment for accuracy and reliability.
• Contribute to development and refinement of QC procedures and work instructions.
• Collaborate with R&D, manufacturing and regulatory teams on quality matters.

Skills

Analytical thinking

Problem-solving

Attention to detail

Communication skills

Education

Bachelor's degree in Science/Engineering

Tools

MS Office

Electronic QMS software

Job description

About the Role

Our client, a leading innovator in the medical device industry, is looking for a dedicated and detail-oriented Remote Quality Control Specialist. This position is fully remote, offering flexibility to candidates across South Africa who meet the qualifications. The successful specialist will be responsible for ensuring that our client's medical devices meet the highest standards of quality, safety, and efficacy through rigorous testing and evaluation processes. You will play a crucial role in maintaining compliance with regulatory requirements and internal quality management systems. This role requires a meticulous approach, strong analytical skills, and the ability to work independently with minimal supervision. As a remote team member, you will leverage technology to collaborate effectively with colleagues based in various locations. This is an exceptional opportunity to contribute to the healthcare sector from the comfort of your own home, ensuring the quality of life-saving medical technologies.

Key Responsibilities

• Perform quality control inspections and tests on incoming materials, in-process components, and finished medical devices according to established procedures and specifications.
• Document all inspection and testing activities accurately, maintaining detailed records in the QMS database.
• Identify, document, and report non-conformances, and collaborate with relevant teams to implement corrective actions.
• Analyze quality data to identify trends, potential risks, and areas for process improvement.
• Ensure compliance with relevant regulatory standards, such as ISO 13485, FDA regulations, and other applicable guidelines.
• Participate in internal and external audits as required, providing necessary documentation and support.
• Maintain and calibrate quality control equipment to ensure accuracy and reliability.
• Contribute to the development and refinement of quality control procedures and work instructions.
• Communicate effectively with cross-functional teams, including R&D, manufacturing, and regulatory affairs, regarding quality matters.
• Stay updated on industry best practices and regulatory changes affecting medical device quality control.

Requirements

• Bachelor's degree in Science (e.g., Biology, Chemistry), Engineering, or a related field.
• Minimum of 3-5 years of experience in quality control or quality assurance, preferably within the medical device or pharmaceutical industry.
• Strong understanding of quality management systems, particularly ISO 13485.
• Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Proficiency in using precision measuring instruments and testing equipment.
• Excellent analytical, problem-solving, and attention-to-detail skills.
• Strong written and verbal communication skills, with the ability to clearly document findings.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and manage time effectively in a remote work setting.
• Experience with electronic QMS software is an advantage.

Benefits

• Competitive salary commensurate with experience.
• Fully remote work arrangement with flexibility.
• Comprehensive health and wellness benefits package.
• Opportunities for professional development and continued learning in the medical device field.
• Contribution to a company that positively impacts global health.
• Retirement savings plan.
• Performance-based bonuses.Company-provided IT equipment and support.
• Access to online training platforms and resources.