Quality Officer

EPM Scientific; Brussel Hoofdstad; Hybrid; EUR 42,000 - 54,000; Full time

Benefits offered by this job

Hybrid work

Medical device environment

Quality projects exposure

Collaborative culture

Job summary

EPM Scientific in Belgium is seeking a Quality Assurance Officer to support and maintain the Quality Management System within a regulated medical device environment. The role focuses on CAPA handling, document control, audits, and continuous improvement across multiple quality processes.

You will work in a hybrid setup (2 days on-site, 3 days remote) and collaborate with cross-functional teams to strengthen quality controls and regulatory compliance.

Qualifications

• Experience within Quality Assurance in medical device industry.
• Knowledge of Quality Management Systems and quality processes.
• Experience with CAPA management, document control and non-conformance handling.
• Familiarity with internal and external audit activities.
• Understanding of applicable quality and regulatory requirements; ISO 13485 knowledge is advantageous.
• Strong organisational skills and attention to detail.
• Ability to work independently while collaborating with cross-functional teams.

Responsibilities

• Manage quality documentation, control and maintenance of quality records and procedures.
• Support the ongoing maintenance and improvement of the Quality Management System (QMS).
• Coordinate CAPAs, ensuring timely closure and effectiveness.
• Support internal and external audits, including preparation of documentation and follow-up of audit findings.
• Investigate non-conformities and quality issues, ensuring appropriate root cause analysis and corrective actions.
• Monitor compliance with internal quality procedures and applicable medical device quality standards.
• Collaborate with cross-functional teams to drive continuous improvement initiatives and strengthen quality processes.
• Assist in the preparation, review and implementation of quality documentation and procedures.

Skills

QA in medical devices

QMS knowledge

CAPA management

Audit experience

Regulatory knowledge

Organisational skills

Independent worker

Job description

Working Pattern: 40 hours per week | Hybrid (2 days on-site, 3 days remote)

Overview

A leading medical device organisation is seeking a Quality Assurance Officer to support and maintain its Quality Management System while ensuring compliance with applicable regulatory and quality requirements.

This position offers the opportunity to work within a highly regulated environment, supporting quality operations across document control, CAPA management, audits, non-conformities and continuous improvement initiatives.

Key Responsibilities

• Manage quality documentation, ensuring accurate control, review and maintenance of quality records and procedures.
• Support the ongoing maintenance and improvement of the Quality Management System (QMS).
• Coordinate and follow up on Corrective and Preventive Actions (CAPAs), ensuring timely closure and effectiveness.
• Support internal and external audits, including preparation of documentation and follow-up of audit findings.
• Investigate non-conformities and quality issues, ensuring appropriate root cause analysis and corrective actions.
• Monitor compliance with internal quality procedures and applicable medical device quality standards.
• Collaborate with cross-functional teams to drive continuous improvement initiatives and strengthen quality processes.
• Assist in the preparation, review and implementation of quality documentation and procedures.

Requirements

• Experience within Quality Assurance in medical device industry
• Knowledge of Quality Management Systems and quality processes.
• Experience with CAPA management, document control and non-conformance handling.
• Familiarity with internal and external audit activities.
• Understanding of applicable quality and regulatory requirements, including ISO 13485 knowledge being advantageous.
• Strong organisational skills with excellent attention to detail.
• Ability to work independently while collaborating effectively with cross-functional teams.

What's on Offer

• Hybrid working model with flexibility.
• Opportunity to work within an innovative and regulated medical device environment.
• Exposure to a broad range of quality activities and continuous improvement projects.
• Collaborative and supportive team culture.