Quality Engineer
Core
Provide quality engineering support for manufacturing processes in the medical device industry to ensure compliance with FDA, ISO, and GMP regulations.
Role type
Quality Engineer (Manufacturing)
Builds
Medical device products and manufacturing processes
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root Cause Analysis, CAPA, Process Validation, Statistical Analysis, Risk Assessment, Change Control, Audit Management, Continuous Improvement, Technical Writing
Preferred skills
CQE/ASQ certification, Bilingual (English/Spanish), Master's degree in Engineering
Technologies
FDA 21 CFR Part 820, ISO 13485, ISO 14971, FMEA, Lean Manufacturing
Responsibilities
Lead investigations into nonconformances and deviations to implement CAPA; Evaluate manufacturing processes to identify trends and reduce defects; Develop and approve quality documentation including procedures and validation reports; Support product and process validation activities (IQ/OQ/PQ); Collaborate with cross-functional teams to incorporate quality requirements; Monitor customer feedback and post-market quality data; Provide quality training to manufacturing personnel.
Seniority
Mid-level, hands-on IC
