Engineer III, QA
Core
Ensure quality excellence and regulatory compliance across manufacturing operations for pharmaceutical, medical device, or biotech products.
Role type
Senior IC Quality Engineer (Regulated Industry)
Builds
Robust quality management systems, validated processes, and compliant product releases
Domain
Life Sciences / Pharmaceutical / Medical Device / Biotech
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA and deviation management, Change control, Risk management and FMEA, Document control, Internal/external auditing, Validation and qualification protocols, Root cause analysis, Statistical analysis, Quality management software
Preferred skills
ASQ certifications (CQE, CQA), Lead Auditor certification, Project management, MS Office proficiency
Responsibilities
Facilitate investigations and root cause analysis for customer complaints or deviations, Perform management reviews, quality reviews, and internal audits, Review validation plans and archive records, Lead projects related to product issues (e.g., Material Review Board), Participate in third-party audits and agency inspections, Prepare audit reports and gap assessments
Seniority
Senior, hands-on IC
