**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** At Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are enabled to realize their full potential as part of a fast-growing, global organization that values passion and outstanding contributions. **Discover Impactful Work:** At the Lenexa site, the Quality Engineering team supports operations to ensure the quality and reliability of medical device products. They collaborate with multi-functional teams such as engineering and validation, track and document defects, and propose effective defect solutions. With a strong understanding of Quality Management System requirements, they support innovative site improvements. **A day in the Life:** + Identify, document, and support operation defects and issues using appropriate tools and methodologies. + Support environmental monitoring and validation requirements throughout the site. + Perform root cause analysis of defects and collaborate on effective solutions to prevent recurrence. + Continuously improve processes and methodologies to improve efficiency and effectiveness. + Generate and review routine metrics to ensure solutions are appropriate. **Keys to Success:** **Education** + Engineering or similar science bachelors degree required. **Experience** + Minimum 3-5 years’ of quality assurance experience in a regulated manufacturing or quality environment. + Familiarity with various quality tools, techniques and methodologies, including investigation tools and metric review and interpretation. **Knowledge, Skills, Abilities** + Knowledge in standards and regulations such as ISO 13485 and/or 21 CFR part 820. + Effective interpersonal communication with multiple levels of staff throughout the organization. + Excellent problem-solving and analytical skills. + Familiarity with GMP and laboratory testing environments. **Benefits** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! **Apply today! http://jobs.thermofisher.com** **Accessibility/Disability Access** Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.