Senior Quality Lab Lead, Medical Devices

Johnson & Johnson MedTech; Nijmegen; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson GATT Technologies in Nijmegen, Netherlands, seeks a Quality Laboratory Lead to oversee the QC team and ensure compliance with ISO 13485, MDR, and related standards. You will manage QC methods, documentation, and release activities for ETHIZIA, our hemostatic patch, while driving continuous quality improvements.

The role emphasizes strong leadership, regulatory knowledge, and the ability to coordinate across QA, manufacturing, and suppliers to prevent quality issues and support

Qualifications

• Diploma from a university or technical college in medicine, science, or engineering.
• 5-8 years in regulated pharma/medical device industry with at least 2 years in management/supervisory role.
• Fluent in written and spoken English.
• Knowledge of 21 CFR Part 820, QSR, ISO 13485, MDR and related regulatory standards.

Responsibilities

• Oversee daily operations of the QC team including training and development of staff.
• Develop, validate and implement QC analytical methods and procedures.
• Review and approve validation and user review documents.
• Maintain SOPs for QC activities, including equipment procedures.
• Ensure equipment maintenance and calibration are performed.
• Manage QC document storage and batch records in cooperation with QA.
• Provide trend data related to QC activities to QA/Data & Trend Specialist.
• Manage stock of QC consumables and equipment.
• Ensure safe QC laboratory operations and lead audit activities.
• Take responsibility for product release and regulatory compliance within QMS.
• Ensure supplier controls for animal materials in accordance with ISO 22442.
• Ensure resources and EHS guidelines are followed by staff.

Skills

Quality Control

Leadership

SOP

Team Management

Compliance Management

Education

University/Technical college degree in medicine/science/engineering

Job description

Johnson & Johnson GATT Technologies in Nijmegen, Netherlands, seeks a Quality Laboratory Lead to oversee the QC team and ensure compliance with ISO 13485, MDR, and related standards. You will manage QC methods, documentation, and release activities for ETHIZIA, our hemostatic patch, while driving continuous quality improvements.

The role emphasizes strong leadership, regulatory knowledge, and the ability to coordinate across QA, manufacturing, and suppliers to prevent quality issues and support