Senior Microbiology & Regulatory Quality Engineer

Jobtailor; Vlaams-Brabant; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

Jobtailor is seeking an experienced biology leader to develop and validate biological and microbiological test methods, driving lifecycle management and continuous lab improvement for medical devices. You will partner with engineering, quality and regulatory teams to ensure regulatory compliance and robust testing capabilities.

You will investigate deviations, lead CAPA actions, and represent the company during audits and inspections, while contributing to cross-functional projects and

Qualifications

• Master's degree or equivalent experience in a lab/regulatory environment.
• Strong expertise in biological/microbiological testing and method validation.
• Solid understanding of ISO standards and regulatory expectations.

Responsabilités

• Lead development, validation, implementation and lifecycle management of test methods.
• Drive continuous improvement of biological/microbiological testing capabilities and lab processes.
• Partner with Product Engineering, Quality and Regulatory Affairs on ISO 10993 testing and risk assessment.
• Investigate deviations and implement CAPA.
• Represent the organization during customer audits and regulatory inspections.
• Contribute scientific expertise to cross-functional improvement and strategic projects.

Connaissances

Biological Testing

Microbiological Testing

Method Development

Validation

Troubleshooting

Data Analysis

Regulatory Requirements

Quality Systems

ISO 10993

Stakeholder Management

Cross-functional Collaboration

Formation

Master's degree in Biology or related field

Outils

Laboratory Technologies

Modern Lab Equipment

Description du poste

Jobtailor is seeking an experienced biology leader to develop and validate biological and microbiological test methods, driving lifecycle management and continuous lab improvement for medical devices. You will partner with engineering, quality and regulatory teams to ensure regulatory compliance and robust testing capabilities.

You will investigate deviations, lead CAPA actions, and represent the company during audits and inspections, while contributing to cross-functional projects and