Investigation-Owner Quality Engineer

Progressive

Leiden

On-site

EUR 60,000 - 90,000

Full time

3 days ago

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Job summary

Progressive is seeking a Quality Engineer (Investigation Owner) to lead quality investigations related to manufacturing processes, products and systems. You will identify root causes, coordinate CAPA actions, document findings, and drive regulatory compliance.

In this role you will collaborate with cross-functional teams, perform GMP-aligned investigations on the production floor, and ensure timely escalation and resolution of quality issues with a strong focus on accuracy and proactive

Qualifications

HBO degree with at least 5 years' relevant experience in investigation leadership within pharma.
Strong analytical and problem-solving abilities with attention to detail.
Excellent communication and teamwork in cross-functional settings.

Responsibilities

Executes routine and non-routine tasks; assembles and leads the team for quality records.
Performs non-conformance investigations, including CAPA records and lead change controls (CC) from initiation through completion.
Reviews documentation for Operations unit processes and products; maintains procedures and updates per regulatory changes.
Ensures compliant documentation and timely completion of quality records.
Initiates and supports risk mitigations and continuous quality improvement projects with limited guidance.
Supports formal escalation processes to ensure visibility of risks related to safety and regulatory compliance.
Conducts GEMBA walks to observe GMP compliance, identify improvements, and implement corrective actions.