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
Job Summary
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.
We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Matching Summary
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.
Skills & Requirements
Must-have
Lead non-conformance investigations
Manage QNs and drive CAPA
Monitor operational performance
Risk management and validation activities
Build quality dashboards and report metrics
Partner cross-functionally
Act as SME in audits
Nice-to-have
Software validation experience desired
Culture of impact with care
Mentoring junior quality staff
Key Requirements
Minimum 5+ years FDA regulated Quality/Manufacturing experience
Experience in quality operations, audit support, process validation/improvement, CAPA, non-conformance and Change/Risk Management (ISO 14971)
Fluent in English (verbal and writing)
Experienced in data analysis/statistics, reporting on key metrics/KPI’s, data visualization/dashboards
Experienced with data analytics tools such as Power BI
Minimum Bachelor's degree in Quality, Engineering, or comparable disciplines