Quality Assurance Manager
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Key skills for this role
Role Overview
Lead and oversee Quality Assurance, Quality Control, and Regulatory Compliance activities for a medical device manufacturing company.
Maintain and continuously improve the Quality Management System, ensure regulatory compliance, support product quality and release, and coordinate with internal and external stakeholders.
The role includes responsibility as Person Responsible for Regulatory Compliance (PRRC).
Key Skills for This Role
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Job Summary
Lead and oversee Quality Assurance, Quality Control, and Regulatory Compliance activities for a medical device manufacturing company.
Maintain and continuously improve the Quality Management System, ensure regulatory compliance, support product quality and release, and coordinate with internal and external stakeholders.
The role includes responsibility as Person Responsible for Regulatory Compliance (PRRC).
Work Arrangement
- The role is full-time and factory or office-based in Dubai, UAE.
- Work location is in person.
Key Requirements
- Bachelor’s degree in Science, Pharmacy, Biomedical Engineering, or a related field.
- Minimum 5 years of relevant industry experience, including at least 2 years in Quality Assurance.
- Experience in medical device manufacturing is highly preferred; pharmaceutical or food manufacturing experience may also be considered.
- Strong knowledge of EU MDR, US FDA, SFDA, MOH, and MENA regulatory requirements.
- Good knowledge of ISO 13485:2016 and ISO 9001:2015.
- Knowledge of CE Marking and Good Manufacturing Practices.
- Experience with technical documentation, quality reports, regulatory documentation, and post-market surveillance.
- English is mandatory; Arabic is an advantage.
Preferred Training and Certifications
- Lead Auditor or Internal Auditor training or certification is preferred.
- Relevant knowledge or training in ISO 13485:2016, ISO 9001:2015, CE Marking, GMP, EU MDR, and medical device regulatory compliance is relevant to the role.
Key Responsibilities
- Develop, implement, monitor, and continuously improve the Quality Management System.
- Ensure quality policies, procedures, work instructions, and quality objectives are effectively implemented.
- Ensure medical devices meet applicable quality and regulatory requirements before release.
- Prepare and maintain technical documentation and the EU Declaration of Conformity.
- Manage post-market surveillance, vigilance, customer complaints, and regulatory reporting.
- Plan and supervise internal audits and participate in external and certification audits.
- Review audit findings and ensure corrective actions and non-conformities are properly addressed.
- Review batch records and support the release of finished products.
- Coordinate with regulatory authorities, certification bodies, Production, QC, Stores, Sales, suppliers, and other departments.
- Lead and supervise the QA/QC and Regulatory Affairs functions.
- Identify training needs and promote continuous improvement and quality awareness.
Compensation
- Pay is AED 15,000–20,000 per month.
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