Engineer, Sr. Quality Assurance
Core
Analyze Quality System data, resolve corrective actions, and ensure compliance with ISO 13485 and 21CFR 820 regulations for implantable neuromodulation devices.
Role type
Senior Quality Assurance Engineer
Builds
Quality Management Systems (QMS) and regulatory compliance for medical devices
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Root cause analysis, CAPA process ownership, ISO 13485 knowledge, 21CFR 820 knowledge, Gap analysis, Lean Six Sigma methodologies, Audit support, Process improvement planning
Preferred skills
Six Sigma certification (ASQ CQE/CQA), Cross-functional project leadership, Enterprise business unit experience, Matrixed environment navigation
Technologies
Lean, Six Sigma tools
Responsibilities
Analyze Quality System data and present metrics to senior management; Investigate and resolve quality system corrective and preventive actions; Support internal and external audits; Develop quality improvement plans considering change impacts; Ensure compliance to ISO 13485 and 21CFR 820; Apply systematic problem-solving methodologies to resolve quality issues; Analyze audit findings and recommend product/process modifications.
Seniority
Senior, hands-on IC