Quality Assurance Engineer

We are looking for an Experienced Quality Assurance Specialist to join our QA Operations group and support the variety of activities related to QA Operations, such as:

• Lead QA Operations activities with regards to verifications/validations for an FDA reviewed complex, multidisciplinary, active investigational device.
• Lead and perform the Engineering Change Order (ECO) process from risk analysis through protocol approval.
• Verification, execution, and analysis of reposts until FDA-ready.
• Provide guidance to the R&D and Engineering teams on IQ/OQ/PV activities.

Qualifications

• B.A. or B.S. degree in a technical discipline, such as Engineering or Science.
• 3-5 years of relevant experience in the medical device industry.
• Previous experience with medical device verification/validations, ECOs, medical device statistics
• Working knowledge of medical device international standards.
• Ability to work independently with minimal work direction and in a cross-functional team environment.
• Fluent in English with excellent writing skills, effective written and verbal communication skills.
• Excellent computer skills, including a working knowledge of Microsoft Office applications.
• Strong time management abilities to ensure timely task completion.
• Detail-oriented.