QA Specialist
Location: Belgium
Start Date: ASAP
Contract Length: 12 months (freelance)
Hours: Full-time - 5 days per week
Working Arrangement: Hybrid
I'm currently partnering with a global life sciences company providing technologies and services that support the development and manufacture of biopharmaceuticals and advanced therapies. I'm seeking a QA Specialist on a contract basis starting ASAP.
What You'll Do
- Provide Quality Assurance expertise across the product lifecycle, ensuring compliance with FDA, EU MDR, ISO 13485, and ISO 14971 requirements.
- Review and maintain key quality documentation including CAPAs, deviations, change controls, risk management files, and validation records.
- Support the development, improvement, and maintenance of Quality Management Systems (QMS).
- Conduct gap assessments and identify compliance risks and quality improvement opportunities.
- Lead or support internal audits, supplier audits, and inspection readiness activities.
- Drive investigations, root cause analysis, and CAPA effectiveness reviews.
- Partner with cross-functional teams including Regulatory Affairs, Manufacturing, Engineering, and Operations.
- Support quality-related projects, remediation activities, and continuous improvement initiatives.
What We're Looking For
- 5+ years of Quality Assurance experience within the medical device, diagnostics, or life sciences industry.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, EU MDR, and quality risk management principles.
- Experience managing QMS processes such as CAPA, audits, supplier quality, change control, and deviations.
- Proven ability to work independently and manage multiple projects in a freelance consulting environment.
- Excellent communication, stakeholder management, and problem-solving skills.
If you're immediately available, please reach out today.
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