Senior Design Quality Engineer
Core
Lead the entire design control process, process validation strategies, and quality audits for FDA-regulated medical devices to ensure regulatory compliance and product quality.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Medical device products and systems
Domain
Healthcare / Medical Devices / Quality Engineering
Required skills
Design Control, Process Validation, Risk Management (ISO 14971), Root Cause Analysis, CAPA, Quality Management Systems (QMS), Regulatory Compliance, Statistical Tools, Post-Market Surveillance (PMS), Design Verification/Validation
Preferred skills
ASQ-CQE, ISO 13485 training, ISO Lead Auditor certification
Technologies
ISO 14971, ISO 13485, QMS tools
Responsibilities
Plan and execute comprehensive process validation strategies using statistical tools; Lead the design control process from inputs to verification, validation, and transfer; Draft and uphold quality engineering documents for hardware, software, and systems; Conduct assessments of product designs and perform root cause analysis; Validate critical design inputs (usability, reliability, safety); Guide risk management activities throughout the product lifecycle; Leverage post-market performance data to assess product effectiveness; Ensure preparation for quality audits and inspections; Execute CAPA processes; Contribute to the development and revision of QMS processes (SOPs, work instructions).
Seniority
Senior, hands-on IC