Quality Engineer 2

Sunrise Systems, Inc. is a leading Medical Device Manufacturing Company seeking a Quality Engineer 2 for an initial duration of 08-09 months on a contract basis. The role involves ensuring quality compliance, data analysis, and regulatory adherence in the medical device industry.

Responsibilities:

• 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)
• Expertise in ETQ Quality Management System
• Experience in the post-market surveillance area (review and investigations of complaints)
• Experience in regulatory compliance and quality systems: CAPA, FMEA
• Knowledge of applicable FDA regulations for medical device industry
• Experience with quality and compliance data
• Experience in Trackwise QMS
• Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized
• Expertise in usage of MS Office Suite
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
• Strict attention to detail

Requirements:

• Bachelor's degree in Engineering, Computer Science, Heath Science
• 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)
• Expertise in ETQ Quality Management System
• Experience in the post-market surveillance area (review and investigations of complaints)
• Experience in regulatory compliance and quality systems: CAPA, FMEA
• Knowledge of applicable FDA regulations for medical device industry
• Experience with quality and compliance data
• Experience in Trackwise QMS
• Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized
• Expertise in usage of MS Office Suite
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
• Strict attention to detail