Medical Analysis jobs

We’re Hiring: Quality Assurance Specialist – Reagent Factory

Location: Dubai, UAE
Company: Nihon Kohden Middle East FZE
Industry: Medical Devices and In-Vitro Diagnostics

Nihon Kohden Middle East, part of a leading Japanese medical device manufacturer, is seeking an experienced Quality Assurance Specialist to oversee the Quality Management System and quality assurance activities of our Reagent Factory in Dubai.

The successful candidate will serve as the appointed Management Representative and MOHAP Technical Manager, ensuring that manufacturing operations, quality controls, documentation and regulatory activities comply with applicable UAE regulations, GMP requirements and international quality standards.

Key Responsibilities Quality Management System:

• Maintain, implement and continuously improve the factory’s Quality Management System in accordance with:
• ISO 9001:2015
• ISO 13485:2016
• GMP requirements
• 21 CFR Part 820
• Applicable UAE statutory and regulatory requirements
• Ensure that the Quality Manual, Standard Operating Procedures, protocols, specifications and other controlled documents are properly prepared, approved, implemented and maintained.
• Establish and update quality assurance procedures to ensure consistency, regulatory compliance and operational effectiveness.
• Monitor the overall performance and effectiveness of the Quality Management System and provide regular reports to the Factory Manager.
• Conduct annual Management Review Meetings with top management and follow up on agreed actions and improvement initiatives.
• Present the factory’s quality performance and compliance status during annual and global quality meetings.

Audits, CAPA and Continuous Improvement

• Plan and conduct internal quality audits at defined intervals.
• Coordinate and support external audits and inspections conducted by regulatory authorities and certification bodies.
• Identify nonconformities and ensure that appropriate corrective and preventive actions are implemented and verified.
• Review, investigate and approve:
• Nonconformities
• Deviations
• Out-of-specification results
• Market and customer complaints
• Change controls
• Corrective and Preventive Actions
• Communicate significant quality issues directly to the Factory Manager and relevant stakeholders.
• Promote continual improvement across the organization through risk-based quality management and effective follow-up of audit findings.

Manufacturing and Batch Release

• Review and approve batch production and control records for each manufactured batch.
• Approve and release finished product batches following completion of the required production and quality control activities.
• Approve raw materials and packaging materials for use in production.
• Reject raw materials, packaging materials or finished products that do not meet approved specifications.
• Review and approve water analysis, in-process testing and finished-product quality control reports in both hard-copy and electronic systems.
• Perform or oversee verification and validation activities, including the assessment of potential defects, errors and process risks.
• Report and investigate incidents, deviations and out-of-specification results.

Regulatory Compliance

• Ensure that quality documentation is maintained in accordance with local regulatory and certification requirements.
• Coordinate the renewal and maintenance of factory-related certificates and approvals through:
• Ministry of Health and Prevention — MOHAP
• Dubai Municipality
• Dubai Civil Defence
• Other relevant authorities
• Communicate and coordinate with regulatory authorities, certification bodies, inspectors and auditors.
• Review and update technical files and approved regulatory documentation in accordance with applicable requirements, including EU IVDR 2017/746.
• Guide relevant departments in updating procedures and documentation following changes in regulatory or quality requirements.
• Maintain effective communication with external organizations involved in the certification and maintenance of the Quality Management System.

Training and Quality Awareness

• Develop and implement quality-related training programmes for employees.
• Deliver or coordinate training on GMP, ISO 9001, ISO 13485 and applicable regulatory requirements.
• Ensure employees understand their responsibilities within the Quality Management System.
• Promote a strong culture of quality, compliance, accountability and patient safety across the factory.

Team Leadership and Global Coordination

• Lead and supervise the Quality Control team.
• Conduct weekly task and performance meetings and ensure timely completion of QC activities.
• Participate in the factory Quality Control Committee and support the effective implementation of quality assurance activities.
• Coordinate with Nihon Kohden sister companies and the Nihon Kohden Corporation quality team.
• Support and complete deliverables required for biweekly Global Quality Meetings.
• Maintain effective collaboration with Production, Regulatory Affairs, Warehouse, Engineering and other relevant departments.

Authorities

The position will be appointed as the:

• Management Representative for the Reagent Factory
• MOHAP Technical Manager
• Authorized person responsible for batch approval and release

The role will also have the authority to:

• Approve or reject raw materials, packaging materials and finished products.
• Approve Standard Operating Procedures and controlled quality documents.
• Approve production, in-process and finished-product quality records.
• Initiate investigations and require corrective actions for quality or regulatory concerns.
• Stop or reject activities, materials or products that do not comply with approved specifications or regulatory requirements.

Candidate Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Biomedical Science, Microbiology, Chemical Engineering or a related scientific discipline.
• Relevant experience in Quality Assurance or Quality Management within the medical device, in-vitro diagnostic, pharmaceutical or healthcare manufacturing industry.
• Strong working knowledge of ISO 9001, ISO 13485, GMP and quality system requirements.
• Familiarity with 21 CFR Part 820 and EU IVDR 2017/746 is highly preferred.
• Experience with batch review, batch release, CAPA, deviations, change control, complaints and internal audits.
• Experience dealing with MOHAP, local regulatory authorities and certification bodies would be an advantage.
• Previous experience as a Management Representative, Technical Manager or authorized batch-release person is preferred.
• Strong leadership, investigation, documentation and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Ability to work effectively in a structured, quality-focused and multicultural environment.

Why Join Nihon Kohden Middle East?

This is an opportunity to join a respected Japanese medical device organization with a strong commitment to quality, innovation and patient safety. The position offers significant responsibility, regional regulatory exposure and close collaboration with local and global quality teams.

Qualified candidates are invited to apply through Indeed and submit their updated CV to vanesa.jahic@nkme.ae

Job Type: Full-time

Pay: AED12,000.00 - AED15,000.00 per month