Sunrise Systems, Inc. · 6 hours ago
Quality Assurance - Engineer 3
Sunrise Systems, Inc. is seeking a Quality Assurance Engineer 3 to develop and implement a compliant and cost-effective quality system for their products and services. The role involves ensuring reliability, safety, and effectiveness in the quality assurance process, particularly within the medical device and healthcare industries.
Responsibilities
Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective
Qualification
Required
Data driven
Strong proficiency in Excel, Power BI and creating dashboards
Independent learner
Focused on driving results and outcomes
Minimum of 2 years experience in Medical Device, Life Sciences or Healthcare industry
Expertise in extracting, filtering, validating and downloading data from Power BI
Expertise in manipulating, and analyzing large datasets using advanced excel functions and formulas (VLOOKUP, pivot tables, conditional formulas)
Experience in the post-market surveillance area (review of data and relationship to complaints)
Understand the importance of quality compliance with medical device industry data
Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards)
Needs to be a quick learner
Used to working in a tight deadline environment
Highly organized
Usage of Power Point, Excel, Word
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
Strict attention to detail
Preferred
Bachelor's degree in Engineering, Computer Science, Health Science
Experience with ETQ Quality Management Systems
Experience in Trackwise QMS
Preferred experience with ETQ Quality Management System
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.