Senior Quality Engineer, Medical Devices & Compliance

• Analyze medical device products for compliance to standards

• Participate in the Design Change process

• Author new SOPs and other documentation

• Review and approve Change Orders (COs), Nonconformance Report (NCRs), Corrective and Preventive Action (CAPA) records

• Work within a cross-functional team to support product development

• Perform Design History File audits

• Provide compliance guidance concerning development, application, and maintenance of quality standards

• Prepare, support, and ensure readiness for audits and inspections

Requirements

• Bachelor of Science (B.S.) degree or higher in engineering
• At least 5 years of experience in engineering or Quality
• Direct experience with FDA inspections, MDSAP audits, ISO 13485 audits
• Experience advising senior leadership and applying pre/post market regulations
• Knowledge of ISO 14971 Risk Management standard
• Knowledge of ISO 62304 Life Cycle Requirements for Medical Device Software
• Knowledge of Medical Electrical Equipment Safety Standards
• Ability to read, analyze and interpret engineering/technical drawings

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Hard Skills

• engineering
• quality assurance
• compliance analysis
• SOP authoring
• design history file audits
• risk management
• technical drawing interpretation
• FDA inspections
• MDSAP audits
• ISO 13485

Soft Skills

• cross-functional teamwork
• communication
• leadership advising
• organizational skills
• analytical skills