About the Role
The Senior Process Quality Engineer will play a key role in strengthening quality processes, supports high-quality performance and compliance across our factories/manufacturing operations.
**Your role:**
+ Lead non-conformance investigations, manage QNs, and drive effective CAPA to prevent recurrence.
+ Drives change management, monitors operational performance, leads defect and non-conformance analysis, and supports investigations and CAPA implementation.
+ Own risk management, validation activities, and MRB processes to ensure product quality and compliance.
+ Monitor quality performance, build dashboards, and report key metrics to senior leadership.
+ Partner cross-functionally with R&D, Manufacturing, and Supplier Quality to resolve systemic issues.
+ Act as SME in audits, strengthen quality systems, and mentor junior quality staff.
**You're the right fit if:**
+ You have a minimum of 5+ years’ experience working in FDA regulated Quality/Manufacturing env...
**Your role:**
+ Lead non-conformance investigations, manage QNs, and drive effective CAPA to prevent recurrence.
+ Drives change management, monitors operational performance, leads defect and non-conformance analysis, and supports investigations and CAPA implementation.
+ Own risk management, validation activities, and MRB processes to ensure product quality and compliance.
+ Monitor quality performance, build dashboards, and report key metrics to senior leadership.
+ Partner cross-functionally with R&D, Manufacturing, and Supplier Quality to resolve systemic issues.
+ Act as SME in audits, strengthen quality systems, and mentor junior quality staff.
**You're the right fit if:**
+ You have a minimum of 5+ years’ experience working in FDA regulated Quality/Manufacturing env...
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