Thermo Fisher Scientific Quality Engineer in Ward Hill, Massachusetts
What will you do?
Provide technical support for CAPA investigations for customer complaints, recurring NCR’s, audit non-conformances, and other investigations using problem solving methodology to identify root cause and implement effective corrective action.
Conduct CAPA effectiveness verification using risk management tools to evaluate impact of changes.
Recommend and implement enhancement to the quality system that result in improved corporate quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs.
Analyze trend data, process capability data and other quality metrics in order to proactively propose specification or process changes. Present findings and recommendations to Quality Management team.
Participate in PPI (Practical Process Improvement) and projects to support achievement of quality and business metrics.
Represent Quality Assurance during change management activities, including configuration management, document control, and procedure control.
How will you get there?
· Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience.
· A minimum of 5 years of experience working with CAPA, complaints, and nonconformance’s in an ISO or cGMP environment.
· A minimum of 2 years of experience working in a chemical industry.
· Proven track record of hands-on problem solving expertise and driving continual improvement in a manufacturing environment.
· Formal training and experience as an ISO Auditor/Lead Auditor a plus.
· Experience reviewing CAPA, complaint, nonconformance documentation
Knowledge, Skills, Abilities
· Results oriented work attitude that exhibits initiative, energy and ability to drive change.
· Excellent interpersonal skills with ability to be a team player and communicate, build and maintain relationships with internal and external customers.
· Advanced proficiency of Excel, Word, PowerPoint, including data analysis and statistical methods.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
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.