Quality Engineer: GMP, CAPA & Change Control

FAMU National Alumni Association; Leiden; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Recognition awards

Job summary

Johnson & Johnson in Leiden, Netherlands, is seeking a Quality Engineer to strengthen the DSP CoE. You will own quality records, manage investigations, CAPA, and change controls, and drive timely, sustainable resolutions across the GMP framework.

You will review quality docs, support audits, and lead risk-based improvement initiatives while coordinating with cross-functional teams in a fast-paced environment.

Qualifications

• HBO degree with 3+ years in quality, manufacturing, or GMP-regulated industry.
• Experience leading or supporting quality investigations and change controls.
• Strong knowledge of GMP, CAPA, Change Control, quality systems, root cause analysis, risk management, and data analysis.
• Fluent English (B2) with strong communication and organizational skills.

Responsibilities

• Apply quality expertise to support Operations objectives, ensuring GMP compliance.
• Lead non-conformance investigations, CAPA records, and Change Controls from initiation to completion.
• Review and maintain quality documentation, procedures, and records.
• Drive continuous improvement through risk mitigation, GEMBA walks, data analysis, and quality projects.
• Support audits/inspections and assist with GMP training initiatives.

Skills

GMP knowledge

CAPA

Change control

Quality systems

Root cause analysis

Risk management

Data analysis

MS Office

Communication

Education

HBO degree

Job description

Johnson & Johnson in Leiden, Netherlands, is seeking a Quality Engineer to strengthen the DSP CoE. You will own quality records, manage investigations, CAPA, and change controls, and drive timely, sustainable resolutions across the GMP framework.

You will review quality docs, support audits, and lead risk-based improvement initiatives while coordinating with cross-functional teams in a fast-paced environment.