Senior Quality Lab Lead - Medical Devices & Compliance

Leiden Bio Science Park; Netherlands; On-site; EUR 70,000 - 110,000; Full time

Job summary

GATT Technologies is seeking a Quality Laboratory Lead for ETHIZIA hemostatic patch, based in the Leiden Bio Science Park. You will oversee the QC team, ensure compliance with ISO 13485 and MDR, and drive continuous quality improvements across manufacturing processes.

You will lead method development, validation, documentation, and audits, while ensuring safe lab operations and strong cross‑functional collaboration with QA and production teams.

Qualifications

• 5-8 years in regulated pharma/medical device industries.
• Management/supervisory experience required.
• Knowledge of ISO 13485, MDR, ISO 22442 and 21 CFR Part 820.
• Excellent leadership, communication and analytical problem solving.
• Fluent written and spoken English.

Responsibilities

• Oversee daily QC team operations, training, and development.
• Develop, validate and implement QC analytical methods and procedures.
• Review validation and user review documents.
• Maintain SOPs for QC activities and equipment.
• Ensure calibration, storage of QC reports, and batch records.
• Provide trend data and support QA data & trend analysis.
• Manage QC consumables, requisites, and equipment stock.
• Lead the QC laboratory for safe operations and high-quality control.
• Act as QC representative for release, NCR, CAPA, deviation, and audits.
• Ensure animal-derived materials are handled per ISO 22442 risk management.

Skills

Quality Control (QC)

Leadership

Mentoring

Analytical skills

Communication skills

Pattern recognition

Decision-making

Strategic planning

Openness to feedback

Fluent English

Education

Diploma in medicine/science/engineering

Job description

GATT Technologies is seeking a Quality Laboratory Lead for ETHIZIA hemostatic patch, based in the Leiden Bio Science Park. You will oversee the QC team, ensure compliance with ISO 13485 and MDR, and drive continuous quality improvements across manufacturing processes.

You will lead method development, validation, documentation, and audits, while ensuring safe lab operations and strong cross‑functional collaboration with QA and production teams.