Quality Assurance Engineer\Sr. Quality Assurance Engineer
Core
Conducts internal quality controls, non-routine quality analysis, and tests/inspections to ensure established quality procedures and norms are followed in a regulated medical device environment.
Role type
Senior IC Quality Assurance Engineer (Medical Devices)
Builds
Quality Management System (QMS) initiatives, validation protocols, and compliant product/process systems
Domain
Medical Devices / Regulated Manufacturing
Required skills
FDA regulations, ISO 13485, CAPA management, Design controls, Risk management, Validation (IQ/OQ/PQ), Root cause analysis, Statistical analysis, Supplier quality, Change control
Preferred skills
Lean Six Sigma, ASQ CQE certification, Mentoring, Process capability studies
Technologies
QMS software, FMEA tools
Responsibilities
Support and lead quality engineering activities for new product development and sustaining engineering; Participate in design verification, validation, risk management, and process validation; Develop and review validation protocols and reports; Ensure compliance with FDA regulations and ISO standards; Support CAPA, complaint investigations, and nonconformance analysis; Collaborate with R&D, Manufacturing, and Regulatory teams; Evaluate product changes and assess impact on quality; Support supplier quality audits and qualification; Utilize statistical analysis for process capability and quality trends; Assist with internal and external audits; Provide technical quality guidance and mentorship.
Seniority
Senior, hands-on IC with leadership responsibilities