Quality Laboratory Lead: Medical Device QC Leader

Biopharma Careers; Nijmegen; Remote; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Nijmegen, Netherlands, seeks a Quality Laboratory Lead to oversee the QC team and ensure high-quality control across ETHIZIA product testing. This role ensures compliance with ISO 13485, MDR and related standards, leads method development, audits, and release activities, and aids continuous quality improvement.

The position requires 5–8 years in a regulated pharma/medtech setting, with leadership experience and strong communication skills.

Qualifikationen

• Degree in science, medicine or engineering from a university or technical college.
• Experience in regulated pharma/medical device environments and QA practices.
• Knowledge of GMP/ISO quality systems and QC methods.

Aufgaben

• Oversee daily QC team operations and training of staff.
• Develop, validate and implement analytical QC methods and procedures.
• Review validation and change-control documents and SOPs.
• Ensure equipment calibration and maintenance is performed.
• Manage QC reports, batch records and qualification documents.
• Support release activities and CAPA/Deviation/audit processes.
• Coordinate stock management of QC consumables and equipment.

Kenntnisse

Leadership

Regulatory knowledge

Quality control

Project management

English proficiency

Ausbildung

University/Technical college degree in science/engineering

Tools

Analytical instruments

Jobbeschreibung

Johnson & Johnson in Nijmegen, Netherlands, seeks a Quality Laboratory Lead to oversee the QC team and ensure high-quality control across ETHIZIA product testing. This role ensures compliance with ISO 13485, MDR and related standards, leads method development, audits, and release activities, and aids continuous quality improvement.

The position requires 5–8 years in a regulated pharma/medtech setting, with leadership experience and strong communication skills.