Quality Assurance Engineer-Medical Devices

Volt Technical Resources has an opportunity for a Sr. Quality Engineer with an exciting client that is an industry leader in the semiconductor industry. This is for their Plymouth location and offers excellent benefits and compensation!Sr Quality Engineer

• Responsible for all aspects of Product Reliability manufactured internally and externally
• Develop qualification strategy in collaboration with R&D and Engineering for both internal and external
• Execute and manages product qualifications
• Assures that qualification will ensure compliance to current company, customers and industry standard reliability goals and requirements including CFR 820 (FDA) and ISO 13485
• Work with R&D and Engineering teams to support the smooth transition of product into Manufacturing.
• Lead root cause Analysis and corrective actions to address Qualification failures

• Minimum BS/BA in scientific or engineering field
• 5+ years of experience in FDA-compliant medical device industry preferably IVD
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
• 5+ years of experience in verification/validation of diagnostic medical products - point of care experience is a plus.