Senior Quality Engineer

Role description

We are searching for the best talent, Senior Quality Engineer. This position can be based in Leiden, The Netherlands.

Key Responsibilities

• Implement Operations unit quality objectives, including performing nonconformance investigations and maintaining procedures.
• Update documentation based on new or revised regulatory requirements, internal investigations, and audits.
• Ensure compliant documentation and timely completion of quality records.
• Initiate and implement risk mitigations and continuous quality improvement.
• Support formal escalation processes to ensure visibility of risks related to safety, product quality, and regulatory compliance.
• Coach less experienced team members in implementing risk mitigations and continuous quality improvement projects for the Operations unit.
• Initiate, drive, and lead cross-functional Operations unit quality improvements with stakeholders.
• Perform and direct comprehensive GEMBA walks to ensure GMP compliance and drive continuous improvement initiatives.
• Support development of training programs for general cGMP processes and act as a Subject Matter Expert on non-conformances and Change Controls during inspections and audits.
• Conduct data analysis on recurring non-conformances and recommend corrective actions.

Qualifications

Education

• A relevant university degree or equivalent experience with 3 years of shown experience (or HBO with 5 years).
• Dutch language level A2 and English language level B2 are required.
• Intermediate proficiency in MS Office, routine proficiency in data analysis, and specialist proficiency in business applications.
• High degree of accuracy and a quality-focused attitude.
• Analytical thinking: ability to handle complexity, ask questions, use data, identify gaps and root causes, and develop creative solutions.
• Positive demeanor, proactivity, decisiveness, and organizational skills; ability to work independently and as part of a team.
• Experience leading team initiatives and ensuring effective collaboration within the team.
• Proven experience leading change controls or quality investigations.

Preferred Skills

• Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management
• Quality-related competencies: Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation
• STEM background and related competencies; Supervision and Technological savviness; Supply Planning