Thermo Fisher Scientific Quality Engineer II, CAPA Specialist in Bedford, Massachusetts
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals!
How you will make an impact:
As a Quality Engineer, II, CAPA Specialist, you will deliver improved processes through the Investigation and CAPA system which will enable us to reduce the number of customer complaints, improve turn around time through targeted investigational work, identifying true root cause and generating robust corrective and preventative actions! The QE II will partner with the operations and engineering teams to facilitate multi-functional investigations and deliver Critical to Quality (CTQ) parameters that support overall site improvement efforts.
What you will do:
Discern and prioritize high risk issues as an impact and risk assessor
Solve problems using root cause analysis tools, such as Cause and Effect Diagrams, 5-Whys…etc.,
Identify and Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances.
Demonstrate team success through verification of effectivity (VOE)
Perform statistical analysis to inform the site of success in delivering to our quality standards (e.g. CAPA, Right First Time)
Engage in our Practical Process Improvement (PPI) culture by participating in Kaizens, Gemba tours and site projects.
Support activities within the Quality Management System adhoc.
How you will get here
- Bachelor of Science (BS) from accredited college/university or equivalent experience. Preferred Science or Engineering Degree
- Minimum of 2 years of relevant Quality/manufacturing/engineering experience in a regulated industry
Knowledge, Skills, Abilities
Accomplished written, oral and presentational skills
Skilled at analyzing data and summarizing results, as well as generating performance metrics to drive improvement
Enjoys working independently and as part of a team, self-motivated, adaptable and a positive demeanor
Have excellent interpersonal, time management, decision-making skills as well as confidence in navigating resolution of conflicting perspectives
Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
General knowledge of ISO 13485 standards and/or FDA cGMP regulations (i.e 21 CFR 820).
Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must. Knowledge of a statistics data software (Minitab, JMP…etc) is highly desirable. Knowledge of TrackWise CAPA Management System is a plus.
Must maintain high ethical standards to support a professional business code of conduct
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.
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