Senior Quality Engineer

The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to develop and verify Class III medical devices for clinical studies. Review and approve engineering and production documents to ensure compliance with design control requirements. Support pilot manufacturing and design verification activities. Must have a good working knowledge of CFR 820, ISO 14971 and ISO 13485.

Main Responsibilities

• Represent Quality Assurance on product development teams.
• Participate in design reviews and technical meetings.
• Review and approve Engineering Change Orders.
• Provide Quality Engineering input to Manufacturing teams and support manufacturing/QC activities.
• Assist with transfer of design to pilot production.
• Drive non conformances to closure through root cause analysis and CAPA.
• Support risk analysis, design assurance, and verification activities for Class III products.
• Support cleanroom and sterilization processes.
• Support quality system activities (CAPA, supplier quality, MRB) and their improvement.
• Must have a good working knowledge of quality aspects of manufacturing, EtO and Steam sterilization,cleanroom and ISO 13485, CFR 820, ISO 14971

Education/Experience

• Bachelor’s degree in engineering (EE or ME preferred) or a related field and/or a combination of 5+ years practical and educational experience in the medical device industry is required
• Fluent with Excel spreadsheets
• Reading engineering drawings (e.g. SolidWorks, AutoCAD, etc.)
• Must have excellent written and verbal communication skill
• Good understanding of CFR 820 and ISO 13485:2016
• Methodical approach to problem solving
• Self-motivated organized team player with high ethical standards
• Site

9/80 work week