Senior Quality Laboratory Lead (MedTech QC)

Johnson & Johnson Co.; Nijmegen; Sur place; EUR 69 000 - 120 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson in Nijmegen, Netherlands, seeks a Quality Laboratory Lead to oversee the QC team and ensure compliant release of ETHIZIA hemostatic patch products.

You will lead method development, validation, and QC activities, align with GMP standards, and drive continuous improvement while coordinating with QA, regulatory, and manufacturing teams to maintain product quality and customer safety.

Qualifications

• 5-8 years in regulated pharma/medical device industry with 2+ years in supervision.
• Knowledge of 21 CFR Part 820, QSR, ISO 13485, MDR, and related standards.
• Fluent in English; strong leadership, communication and problem-solving skills.
• Auditing/regulatory compliance experience is preferred.

Responsabilités

• Oversee daily QC team operations, training, and development.
• Lead development, validation, and implementation of QC methods.
• Review validation and user-review documents; ensure SOP compliance.
• Maintain equipment, calibration, and QC records; manage stock.
• Support release decisions and CAPA, deviations, and audits.

Connaissances

Leadership

Mentoring

Communication

Analytical

Regulatory knowledge

English fluency

Formation

University degree in science/engineering

Description du poste

Johnson & Johnson in Nijmegen, Netherlands, seeks a Quality Laboratory Lead to oversee the QC team and ensure compliant release of ETHIZIA hemostatic patch products.

You will lead method development, validation, and QC activities, align with GMP standards, and drive continuous improvement while coordinating with QA, regulatory, and manufacturing teams to maintain product quality and customer safety.