NL - Engineer 3, Quality Engineering
| Location | Leiden, Netherlands |
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| Business Sector | Pharmaceutical |
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| Contact email | |
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| Job ref | 27744 |
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| Published | 4 days ago |
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Quality engineer (investigation owner) Job description
The Quality Engineer (Investigation Owner) is responsible for leading and managing quality investigations related to manufacturing processes, products, and systems. This role involves identifying root causes of quality issues, coordinating corrective and preventive actions, and ensuring compliance with internal standards and regulatory requirements. The Quality Engineer works closely with cross-functional teams to document findings, drive process improvements, and communicate results to stakeholders. Strong analytical skills, attention to detail, and effective problem-solving abilities are essential for success in this position.
Essential Job Duties and Responsibilities
Experienced individual contributor that executes tasks that are both routine and not routine. Assembles and leads the team required for quality records. Escalates issues and risks as required. Demonstrates effective communication skills. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.
Specific tasks and job duties of the position that are required daily:
• Applies expertise knowledge of Quality requirements to support the handling of quality records
• Perform non-conformance investigations, including CAPA records and lead change controls (CC) for the operations unit from initiation through completion.
• Reviews documentation associated with processes and activities for the Operations unit products.
• Maintains procedures and applicable documentation and makes updates based on new or revised regulatory requirements, internal investigations, and audits.
• Ensure compliant documentation and timely completion of quality records.
• Initiates and implements risk mitigations and continuous quality improvement projects, under limited guidance.
• Supports with formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.
• Perform regular GEMBA walks to observe and document adherence to GMP standards on the production floor, identify areas for improvement, and collaborate with team members to implement corrective actions.
Minimum Qualification
• A relevant HBO degree with 5 years relevant experience, in an investigation lead, Quality engineer, or similar role within pharmaceutical industry.
• English B2 language level is required.
• The levels of computer proficiency are intermediate level for MS office, routine level for data analysis, and specialist level for business applications.
• Positive attitude, proactivity, decisive, and organized with an ability to work individually and in a team.
• Stress-resistant, continues to work calmly under all circumstances.
• High degree of accuracy and quality attitude.
• Flexible, can deal with changing priorities.
• Shows accountability by proactively addressing issues and taking responsibility for outcomes.
• 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.
• Prioritize tasks effectively to meet deadlines and ensure timely delivery.
• Maintains effective alignment with stakeholders and establishes meaningful connections with customers.