Senior Quality Engineer
Core
Ensure product and process quality, patient safety, and regulatory compliance across manufacturing operations in a medical technology environment.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Manufacturing processes, validated quality systems, and compliant medical devices
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, risk management methodologies, statistical sampling plans, process validation, change management, audit leadership, process capability analysis, gauge R&R, Lean Six Sigma
Preferred skills
ISO 13485, GMP, GDP knowledge, process optimization, statistical techniques
Technologies
None explicitly stated
Responsibilities
Partner with manufacturing teams to improve quality performance; lead nonconformance and corrective/preventive action activities; drive continuous improvement initiatives; review and approve change management activities; lead quality activities for process development and validation; apply risk management to strengthen process controls; optimize inspection methods and process monitoring; support internal and external audits and regulatory interactions.
Seniority
Senior, hands-on IC