Senior Quality Engineer

About the role

NovintiX is seeking a Senior Quality Engineer to lead end‑to‑end NC/CAPA governance within GMP‑regulated pharmaceutical environments. The role focuses on moderation of governance meetings, escalation management, KPI visibility, root‑cause analysis (RCA) facilitation, and RCPS coaching to improve investigation effectiveness across multiple functions.

Key responsibilities

• Moderate daily NC/CAPA governance meetings and ensure structured discussions.
• Coordinate cross‑functional stakeholders from Operations, MSAT, QA, Engineering, GET and support functions.
• Challenge teams on governance processes, timelines, escalation discipline and operational follow‑through.
• Drive governance discipline, track actions, and enforce operational accountability.
• Monitor participation, meeting adherence and stakeholder engagement.
• Trend and analyse NC/CAPA activity, recurrence patterns, aging metrics and escalation risks.
• Facilitate RCA discussions and RCPS workshops for complex investigations and recurring issues.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or a related technical discipline.
• 8–10 years of experience in NC/CAPA governance, Operational Excellence or GMP‑regulated operations.
• Hands‑on experience in pharma/GMP environments and moderating cross‑functional governance forums.
• Proven experience in RCA facilitation and RCPS coaching methodologies.
• Lean Green Belt or Black Belt; RCPS certification preferred.
• Strong understanding of GMP, quality systems and the NC/CAPA lifecycle.
• Excellent communication, stakeholder coordination and escalation management skills.
• Dutch‑speaking capability is mandatory.

Required skills

• NC/CAPA governance
• Root‑cause analysis (RCA) facilitation
• RCPS coaching methodology
• Lean Green Belt / Black Belt
• GMP and quality‑system knowledge
• Operational Excellence frameworks