Supplier Quality Specialist

Quality Systems & Supplier Quality Specialist (Compliance & Remediation)

Location: Brussels, Belgium (3 days onsite / 2 days remote)

Contract: 12 months

Overview

We are seeking a proactive and detail-oriented Quality Systems & Supplier Quality Specialist to support a key compliance and remediation programme within a global medical device organisation.

This role sits at the intersection of internal Quality Management Systems (QMS) and Supplier Quality, with a strong focus on GAP assessments, remediation execution, and audit readiness across global operations, including APAC regions.

Key Responsibilities

Quality Systems & Compliance

• Conduct GAP assessments against applicable regulations and standards (e.g. ISO 13485, MDR, FDA)
• Support and execute remediation plans, ensuring timely closure of identified gaps
• Contribute to audit readiness activities (internal audits, external audits, Notified Body inspections)
• Ensure adherence to internal procedures, quality standards, and regulatory requirements

Supplier Quality

• Support supplier qualification, monitoring, and compliance activities
• Participate in or coordinate supplier audits
• Manage and follow up on supplier non-conformances, CAPAs, and SCARs
• Ensure supplier processes align with internal QMS and regulatory expectations

Stakeholder & Project Management

• Act as a key point of contact between internal teams (QA/RA/Operations) and external stakeholders
• Collaborate with global teams, including APAC regions, ensuring effective communication and alignment
• Track and report progress on remediation and quality initiatives
• Identify risks and escalate issues appropriately

Documentation & Systems

• Maintain accurate and compliant documentation related to quality activities, assessments, and remediation actions
• Support the use of quality and business systems for tracking and reporting (e.g. eQMS, Excel)

Candidate Profile

Experience

• 3+ years' experience in:
• Quality Assurance
• Regulatory Compliance
• Supplier Quality (preferred combination)
• Experience in GAP assessments and remediation programmes is essential
• Exposure to medical devices or other regulated industries strongly preferred

Skills & Expertise

• Strong knowledge of:
• QMS frameworks (ISO 13485, FDA, MDR)
• Audit processes and compliance requirements
• Experience managing:
• Non-conformances, CAPA, and supplier quality issues
• Ability to work across:
• Internal teams and external suppliers
• Global stakeholders (APAC exposure is a strong advantage)
• Proficiency with:
• Excel and quality systems (eQMS / ERP / GPAO-type systems)

Soft Skills

• Excellent stakeholder management and communication skills
• Highly organised, methodical, and detail-oriented
• Proactive with a solution-driven mindset
• Strong team player with the ability to work independently in a fast-paced environment