Quality Manager

About Us:

The Xen Group, comprising Xenith LLC in the UAE and Qudra Medical LLC in Oman, has been dedicated to delivering innovative medical products to patients since 2002. Our commitment to knowledge dissemination and our highly trained sales force are key drivers of our success. We partner with some of the world's leading medical manufacturers to bring cutting-edge devices to the UAE and Oman, ensuring that healthcare providers in these regions have access to the latest advancements in medical technology.

Quality Manager

Department:
Quality & Regulatory

Reports To:
Senior Management

Location:
[Dubai / UAE – adjust as needed]

Role Overview

We are seeking a hands-on
Quality Manager
to establish, structure, and lead the Quality function from the ground up. This role is responsible for developing and improving SOPs, enforcing document control standards, managing complaints and CAPAs, and embedding a strong quality culture across the organization.

This is a
builder role
— ideal for someone who enjoys creating systems, improving processes, and driving compliance rather than maintaining an already mature setup.

Key Responsibilities
Quality System Development

• Set up and structure the
  Quality Department
  from scratch
• Design, implement, and maintain the Quality Management System (QMS)
• Establish quality policies, procedures, and governance frameworks aligned with business needs
• Ensure compliance with applicable standards (e.g. ISO 13485 / GDP / internal quality requirements, as applicable)

SOPs & Process Improvement

• Review, rewrite, standardize, and optimize existing SOPs
• Identify gaps in documentation and create new SOPs where required
• Ensure SOPs are practical, auditable, and actually followed
• Drive continuous improvement initiatives across departments

Document Control & Standards

• Implement and manage document control systems (creation, review, approval, version control, archival)
• Define document templates, naming conventions, and quality standards
• Train teams on document discipline and quality expectations
• Ensure traceability and audit readiness at all times

Complaints, CAPA & Non-Conformances

• Establish and manage the
  complaints handling process
• Lead investigations into complaints, deviations, and non-conformances
• Define and track Corrective and Preventive Actions (CAPA)
• Perform root cause analysis and ensure timely closure

Training & Quality Culture

• Develop quality training programs for staff across departments
• Promote a culture of quality, accountability, and compliance
• Act as a quality business partner rather than a "police function"

Audits & Reporting

• Prepare for and support internal and external audits
• Conduct internal audits and follow up on findings
• Report quality metrics, trends, and risks to senior management
• Act as the primary quality point of contact for inspections and audits

Required Qualifications & Experience

• Bachelor's degree in Life Sciences, Engineering, Quality, or related field
• 5–8+ years of experience in a Quality role (medical devices / pharma / healthcare preferred)
• Proven experience
  setting up or significantly improving
  a QMS
• Strong SOP writing and document control experience
• Hands-on experience with complaints handling and CAPA
• Solid understanding of ISO 13485 and/or similar quality standards
• Experience working in regulated environments (Pharma experience is a plus)

Skills & Competencies

• Highly structured and detail-oriented
• Strong process and systems thinker
• Excellent written communication (SOPs, reports, procedures)
• Confident working cross-functionally with operations, sales, logistics, and management
• Pragmatic mindset — able to balance compliance with business realities
• Comfortable challenging existing processes and driving change

What Success Looks Like in This Role

• A fully functional, audit-ready Quality Department
• Clear, standardized, and effective SOPs across the business
• Strong document control discipline
• Efficient and well-managed complaints and CAPA processes
• Improved quality awareness and ownership across teams