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.

Requirements:

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.

Reports to:

QA Manager