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
FAQs
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