QA Specialist

EPM Scientific; Brussel; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

EPM Scientific partners with a global life sciences company to recruit a QA Specialist for a contract role in Belgium, starting ASAP. You will provide Quality Assurance expertise across the product lifecycle and ensure compliance with ISO 13485, EU MDR, and FDA requirements.

You will review CAPAs, deviations, change controls, risk management files, and validation records; support QMS improvements; conduct gap assessments; and lead or support internal and supplier audits.

Qualifications

• 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.

Responsabilités

• Provide QA expertise across the product lifecycle, ensuring compliance with regulatory requirements.
• Review and maintain CAPAs, deviations, change controls, risk management files, and validation records.
• Support 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 and continuous improvement initiatives.

Connaissances

Quality Assurance

Regulatory compliance

ISO 13485

FDA 21 CFR Part 820

EU MDR

CAPA Management

Audits

QMS

Description du poste

I'm currently partnering with a global life sciences company providing technologies and services that support the development and manufacture of medical devices. 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.