Quality Engineer Iii – Quality Complaint Management
Thermo Fisher Scientific UK
Minnesota, United States
Base: $75,800.00–$113,675.00; bonus: eligible for ...
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Bachelor's degree in engineering or life sciences
3-5 years qa experience in regulated industry
Strong knowledge of cgmp, iso 13485/9001, fda regulations
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Thermo Fisher Scientific is seeking a Quality Engineer III for Quality Complaint Management, responsible for overseeing the customer complaint quality management system and ensuring regulatory compliance. The ideal candidate should have a Bachelor's degree, 3-5 years of experience in quality assurance, strong analytical skills, and proficiency in quality management systems.
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Job Summary
This role involves overseeing the customer complaint quality management system while ensuring compliance with FDA, cGMP, and ISO regulations.
The position requires collaborating cross-functionally to resolve quality issues through robust investigations and risk assessments.
Employees receive a comprehensive Total Rewards package including medical plans, 120 hours PTO, paid holidays, and a competitive 401(k) plan.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific is seeking a Quality Engineer III for Quality Complaint Management, responsible for overseeing the customer complaint quality management system and ensuring regulatory compliance. The ideal candidate should have a Bachelor's degree, 3-5 years of experience in quality assurance, strong analytical skills, and proficiency in quality management systems.
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Salary
Base: $75,800.00–$113,675.00; Bonus: Eligible for variable annual bonus based on performance; Benefits: Comprehensive medical, dental, vision, 401(k), ESPP, and 120 hours PTO
Skills & Requirements
Must-have
Bachelor's Degree in Engineering or Life Sciences
3-5 years QA experience in regulated industry
Strong knowledge of cGMP, ISO 13485/9001, FDA regulations
Expertise in root cause analysis and problem-solving methodologies
Proficiency with Quality Management Systems (QMS)
Experience managing customer complaint handling systems
Nice-to-have
ASQ certifications (CQE, CQA) desired
Ability to travel up to 10%
Additional language skills are a plus
Strong project management and organizational skills
Effective interpersonal skills to influence cross-functional teams
Key Requirements
Bachelor's Degree required
3-5 years experience in pharmaceutical, medical device, or biotech
ASQ certifications (CQE, CQA) preferred
Working knowledge of statistical analysis and quality tools