Ensure medical device history record review, final acceptance, and final product release meet specified standards
Requirements
- Bachelor's degree from an accredited university or college (or at least 6 years of relevant work experience in Medical Devices, or similar regulated industry)
- Minimum of 4 years of experience working in a regulated industry
- Quality Assurance or Quality Engineering experience in medical devices or experience in design engineering or manufacturing engineering in the medical device field
- Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
- Aptitude with digital workflows and IT systems
Responsibilities
- Provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members as applicable
- Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, corrective, and preventive actions (CAPA)
- Utilizes risk management tools in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.
- Drives implementation of lean processes and standard work
- Applies technical expertise and judgment to solve problems, drawing on cross-functional resources as needed
- Performs a broad variety of tasks in support of product and process design
Other
- Legal authorization to work in the U.S. is required
- Strong oral and written communication skills
- Ability to effectively prioritize and execute projects to plan
- Exceptional analytical, problem solving & root-cause analysis skills
