A medical device is seeking an experienced Quality Assurance Engineer to join the QA Operations team and support a variety of activities related to QA Operations::
Managing Supplier Quality Issues and coordinating cross-functional activities with Engineering, Purchasing, Manufacturing, and R D to resolve supplier quality issues and minimize production impact.
Resolving nonconformances identified during Incoming Quality Control (IQC) inspections.
Review and assess incoming inspection failures to determine the appropriate disposition and escalation path, and to continuously improve incoming inspection processes.
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 act
Requirements: B.A. or B.S. degree in a technical discipline, such as Engineering or Science.
3-5 years of relevant experience in a Quality Engineering role in the medical device industry.
Previous experience with medical device Quality issues investigation, verification/validations, ECOs.
Strong understanding of Quality Management Systems (QMS) and applicable standards, including ISO 13485 and FDA 21 CFR Part 820 (or FDA QMSR).
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 and project management abilities
Detail-oriented.
This position is open to all candidates.