Quality Engineer

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 a real-world impact, and you'll be supported in achieving your career goals.

Division Specific Information

Life Sciences Solutions Group - Chelmsford, MA

How will you make an impact?

As? a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineer subject matter expert. As a key part of the quality and product management teams, you will drive continuous improvement of product quality and customer satisfaction through effective application and enhancement of the established quality management system and systematic monitoring and analysis of identified quality indicators. You will build and keep track of Quality KPI's working with internal and external manufacturing partners and drive improvements. You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall customer satisfaction efforts.

What will you do?

· Serve as a primary quality team member for third-party manufactured devices within the Laboratory Products and Water Purification segments.

· Serve on the Laboratory Equipment and Water Purification segment product leadership teams

· Coordinate and drive solutions to poor customer quality experiences with the supplier, engineering and the service organization.

· Oversee compliance and drive Quality Agreements, Certificates of Conformances, site certificates, etc. for segment's suppliers.

· Implement Supplier corrective and preventative actions (SCARS) to prevent recurrence of deviations and non - conformance's. Verify the effectiveness of implemented changes utilizing the proper quality tools.

· Lead Customer Focused Improvement Team meetings including Quality, Product Management, Engineering, and Service Teams.

· Gather and analyze data (ex Pareto Analysis) to drive action and focus on the more impactful product improvements.

· Provide guidance for the disposition of non-conforming material (final product and raw material).

· Have an expert level knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma and control plans.

How will you get here?

Education

A Bachelor's Degree in a Scientific/Engineering discipline is required

Experience

A minimum of 4 years' experience in Quality Engineering, Manufacturing Engineering or Supplier Quality Management progressive role.

Equivalent:

Equivalent combinations of education, training and relevant work experience may be considered.

Knowledge, Skills, Abilities

· Strong verbal and written communication skills in English.

· Ability in technical and statistical writing.

· Must have experience in processes and procedures of ISO-9001: 2015

· Lean Sigma Green or Black Belt certified, preferred.

· Ability to work in a matrix organization.

· Strong analytical, problem resolution, judgment and decision-making skills

· Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective/preventative actions.

· Prior experience with the release and disposition of nonconforming products through the application of risk assessment and root cause analysis tools.

· Excellent organization skills with strong attention to details.

· Ability to multitask efficiently to support production demand.

· Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must.