Quality Assurance Engineer\Sr. Quality Assurance Engineer
Core
Conduct internal quality controls, non-routine analysis, and tests/inspections to ensure quality procedures are followed in a regulated medical device environment.
Role type
Quality Assurance Engineer / Senior Quality Assurance Engineer (IC)
Builds
Medical devices and related quality systems
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulations, ISO 13485, CAPA management, Design controls, Validation (IQ/OQ/PQ), Root cause analysis, Statistical analysis, Supplier quality, Risk management, 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 execute validation protocols and reports; Ensure compliance with FDA and ISO standards; Support CAPA, complaint investigations, and nonconformance analysis; Evaluate product changes for quality and regulatory impact; Collaborate with R&D, Manufacturing, and Regulatory teams; Support supplier qualification and audits; Utilize statistical analysis for process capability and quality trends; Participate in internal and external audits; Provide technical guidance and mentorship at senior levels.
Seniority
Mid-level (0-3 years) to Senior (6+ years, hands-on IC with leadership)
