Sr Design Quality Engineer
Core
Senior Quality Engineer owning Quality Assurance, Document Control, and Design Control for MedTech product lines, ensuring regulatory compliance and driving continuous improvement.
Role type
Senior IC Quality Engineer (Design Control & QA)
Builds
MedTech products and processes
Domain
Medical Technology / Regulatory Quality
Required skills
FDA regulated environment experience, product design experience, Quality Engineering in regulated environments, statistical analysis, risk management (FMEA/FMECA/FTA), root cause analysis, CAPA planning, audit execution, Design History File development, cross-functional leadership, mentorship
Preferred skills
ASQ Certification
Technologies
None stated
Responsibilities
Serve as Quality representative on cross-functional teams applying Design Control principles; Author, review, and approve Quality System documentation including CAPAs and audit reports; Develop and approve product quality documentation like Design History Files; Create and approve validation protocols for products, processes, and software; Lead risk management activities including FMEA and FTA; Analyze nonconformances and drive CAPA plans; Perform internal and supplier quality audits; Investigate product complaints; Monitor quality metrics and trends; Partner with manufacturing sites for compliance; Chair Design Reviews; Mentor and supervise quality professionals and engineers; Communicate industry trends and regulations to the business
Seniority
Senior, hands-on IC with mentorship responsibilities