We are looking for a Quality Manufacturing Engineer to oversee quality assurance activities within the factory. In this role, you will work closely with Operations and Manufacturing Engineering to manage deviations, changes, non-conformities, and escalations, ensuring compliance with applicable procedures and driving continuous improvement across manufacturing processes.
Responsibilities
- Address non-conformities within production and manage internal escalations.
- Guide and oversee planned deviations from established production processes.
- Review, advise on, and approve changes to production processes in accordance with applicable procedures.
- Analyse production rejection data to identify trends, reduce process variation, and eliminate root causes of quality issues.
- Identify and recommend improvements based on significant performance trends, reporting findings to management and relevant cross-functional teams.
- Manage non-conformities and investigate and resolve Corrective and Preventive Actions (CAPAs).
- Drive continuous improvement in response to regulatory developments, emerging trends, deviations, and data-driven insights.
- Write, review, and support the development and updating of operating procedures.
Qualifications
- A university degree, Bachelor's degree, or equivalent qualification.
- 4–6 years of relevant work experience, preferably within the pharmaceutical or medical-device industry.
- Excellent command of both Dutch and English, written and spoken.
- Flexible, detail-oriented, and accurate working style.
- Ability to work independently as well as collaboratively within a team.
Nice to Have
- Experience in quality assurance within a pharmaceutical or medical-device manufacturing environment.
- Familiarity with non-conformity management, CAPAs, and manufacturing process deviations.
- Experience analysing production quality data and implementing continuous improvement initiatives.
- Knowledge of regulatory requirements and quality management procedures in a regulated manufacturing environment.
Practicalities
- Location: Groningen, the Netherlands
- Language: Dutch and English