Quality Assurance Lead

• Around 5 years’ experience in Quality Assurance either in Medical Device manufacturing or Pharma industry. 

• Proven experience working with local and international regulations including Risk Management principles:

     - EU MDR 2017 /745

    - ISO 13485

#LI-JL1

• QMS Management and Maintenance: Maintain and continuously improve the ISO 13485-aligned QMS.. Ensure all quality procedures, policies, forms, and work instructions are controlled and up to date.
• Regulatory Compliance with applicable regulations
  • EU MDR 2017/745
  • ISO 13485 requirements relevant to distributors
• Develop and maintain an annual internal audit schedule.
• Non-Conformance and CAPA Management. Manage product, process, and QMS non-conformities.
• Qualify and approve suppliers, logistics providers, and service providers.
• Oversee customer complaint management processes
• Product Traceability and Distribution Controls
• Storage and Environmental Control. Ensure storage conditions meet requirements.
• Ensure employees are trained on quality procedures.
• Risk Management. Identify quality and compliance risks within the distribution process.
• Manage quality-related change controls
• Maintain recall and field safety corrective action procedures.
• KPI and Quality Reporting
• Certification Readiness (ISO 13485 Certification)

• Around 5 years' experience in Quality Assurance either in Medical Device manufacturing or Pharma industry.

• Proven experience working with local and international regulations including Risk Management principles:

  - EU MDR 2017 /745

  - ISO 13485

#LI-JL1