Quality Laboratory Lead (MedTech)

Location: Nijmegen, Netherlands

Base pay: €68,600–€119,600 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including ETHIZIA, an innovative hemostatic sealing patch.

What you will do

• Lead the daily operations of the Quality Control laboratory, including training, qualification, coaching, and development of QC employees.
• Develop, validate, and implement analytical methods and procedures for routine inspection, testing, and evaluation.
• Review and approve validation and user review documents, maintain QC SOPs, and ensure equipment maintenance and calibration.
• Manage QC records, batch documentation, qualification reports, validation documents, consumables, and laboratory equipment.
• Represent QC in product release, NCR, CAPA, deviation, and audit activities.
• Ensure supplier control and risk management for animal-derived materials in compliance with ISO 22442.

Requirements

• University or technical college diploma in medicine, science, engineering, pharmacy, or a related field.
• 5–8 years of experience in a regulated pharmaceutical or medical-device industry, including at least 2 years in a management or supervisory role.
• Working knowledge of ISO 13485, ISO 22442, 21 CFR Part 820, EU MDR, Canadian medical-device regulations, Japanese requirements, Brazil GMP, and other applicable standards.
• Leadership, mentoring, communication, analytical, decision-making, and strategic-planning skills.
• Fluent written and spoken English required.

Nice to have

• Experience with medically regulated plant operations and FDA cGMPs.
• Experience with audits involving notified bodies or competent authorities.
• Experience enhancing quality-system processes while maintaining regulatory compliance.
• Dutch language skills.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and individual contribution.
• Annual bonus based on pay grade, location, and individual and company performance.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Service anniversary and recognition awards, with participation in applicable insurance plans.