Supplier Quality Auditor
$75,000–$100,000 year
On-site · Zaventem, Flanders, Belgium
Job Summary
As a Supplier Quality Auditor, you will conduct audits of suppliers to ensure compliance with regulatory and quality standards, manage action plans from audits, and escalate quality issues as needed. You will work with cross-functional teams to resolve supplier issues, report on supplier quality KPIs, and maintain accurate audit documentation. Requirements include a Bachelor’s degree in Engineering, relevant quality auditor certifications, 2-5 years in medical device manufacturing, and working knowledge of cGMP and ISO-13485. Proficiency in English is required, with a second language as a plus.
Required Qualifications
- Bachelor’s degree in Engineering (Biochemical, Chemical, or related field).
- Quality Auditor, with an accreditation record such as ASQ (American Society for Quality) CQA (Certified Quality Auditor) or CBA (Certified Biomedical Auditor), IRCA Lead Auditor Registration, RABQSA Lead Auditor Certification or equivalent government body certification.
- 2-5 years’ experience in medical device manufacturing or a related industry.
- Working knowledge of cGMP, CFR 820, ISO-13485.
- Experience with master validation plans, protocols, and reports (IQ, OQ, PQ) and risk management (pFMEAs) process and documentation.
Desired Qualifications
- Problem Solving: Knowledgeable of problem-solving tools such as SPC, Total Quality Management, and root cause analysis.
- Strong Communicator: Ability to effectively communicate at all levels of the organisation, both written and verbal.
- Analytical Mindset: Skilled at analyzing data, evaluating factors, and translating insights into actionable plans.
- Self-Motivated: Able to work independently with minimal supervision, while managing multiple complex projects.
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