Quality Assurance Engineer at Tosoh Bioscience, Inc. · Grove City, OH · Joined
TI
Quality Assurance Engineer
Tosoh Bioscience, Inc. · Grove City, OH · Just now · 0 applicants
NewOn-siteFull-timeSenior
Pay
Pay not listed
Workplace
On-site
Job type
Full-time
Level
Senior
Source: jobright · Posted by joined-scrapper
About the role
Tosoh Bioscience is seeking a Senior Quality Assurance Engineer to support and improve its Quality System in compliance with FDA and ISO requirements. The role involves cross-functional engineering support through validation and data monitoring in an IVD manufacturing environment.
What you’ll do
Support and continuously improve the company's Quality System
Ensure compliance with applicable FDA and ISO requirements
Provide cross-functional engineering support through validation and data monitoring
What you’ll need
Minimum of five years of relevant facilities and/or manufacturing IVD industry experience in an FDA-regulated or ISO13485 environment
Understanding of Contract Manufacturing versus Manufacturer of Record quality and regulatory cGMP requirements for Facilities, Operations, and Manufacturing
Organizational, planning and detailed follow-up skills
Ability to use tasking, scheduling, and project management tools
Ability to work independently and across functional teams
Excellent communication, verbal, written, and interpersonal skills
Original job description
Tosoh Bioscience, Inc. develops diagnostic systems for clinical and laboratory settings. The Quality Assurance Engineer supports and continuously improves the company’s Quality System in compliance with applicable FDA and ISO requirements, providing cross-functional engineering support through validation and data monitoring.Minimum of five years of…