Senior Quality Engineer

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

What you will be doing: As a Senior Quality Engineer within the DSP CoE department, you'll be pivotal in ensuring our quality management systems are top-notch. You'll apply your expertise in quality requirements to support the execution of Operations unit objectives. Your role will involve performing nonconformance investigations, including CAPA records, and leading change controls from initiation through completion. This role requires someone who takes clear ownership of records and gives guidance to support team members, makes sure accountability for timelines, and drives timely, sustainable resolutions.

Key Responsibilities:

• Your expertise will be crucial in implementing Operations unit quality objectives, such as performing nonconformance investigations, maintaining procedures, and making updates based on new or revised regulatory requirements, internal investigations, and audits.
• You'll ensure compliant documentation and timely completion of quality records.
• You'll initiate and implement risk mitigations and continuous quality improvement
• You'll support formal escalation processes to ensure visibility of risks associated with safety, product quality, and regulatory compliance.
• You'll coach less experienced employees in the implementation of risk mitigations and continuous quality improvement projects for the entire Operations unit.
• You’ll initiate, drive, and lead cross-functional Operations unit quality improvements in close collaboration with stakeholders.
• You’ll perform and direct comprehensive GEMBA walks to ensure full GMP compliance, drive continuous improvement initiatives.
• You'll support the 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.
• You'll 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 A2 and English B2 language levels are required.
• Intermediate proficiency in MS Office, routine proficiency in data analysis, and specialist proficiency in business applications.
• High degree of accuracy and quality attitude.
• Analytical thinking: ability and dealing with complexity, asking questions, using data, using information and identify gaps and root causes of issues and think out of the box to develop a solution.
• A positive demeanor, proactivity, decisiveness, and organizational skills, with the ability to work independently and as part of a team.
• Strong analytical thinking, with the ability to handle complexity, ask questions, use data, identify gaps and root causes of issues, and think creatively to develop solutions.
• Stress-resilience, maintaining calm under all circumstances, flexibility, and the ability to handle changing priorities.
• Experience with leading team initiatives (ability to give clear direction and ensuring effective collaboration within the team).
• Proven experience with leading change controls or quality investigations.

Preferred Skills:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

Hybrid Work