Thermo Fisher Scientific Quality Assurance Engineer in Branford, Connecticut

Job Description

Job Description

Position Summary:

The Quality Engineer is responsible for performing Software Quality Assurance activities throughout the Quality Management System with a particular focus on the Software Development Lifecycle. The Software Quality Engineer should have a strong background in process improvement techniques and software development methodologies.

Key Responsibilities:

  • Assume the Quality Assurance role in SDLC processes which involves working with R&D to ensure requirement traceability, adequate change control and process compliance.

  • Drive process improvement activities across the business unit.

  • Facilitate process improvement projects with people at all levels in the organization.

  • Host (or assist with hosting) pre-sales and routine customer audits.

  • Host (or assist with hosting) ISO 9001 audits.

  • Conduct internal audits of Quality Management System ensuring corrective actions are in alignment with overall business strategy.

  • Conduct (or assist with) supplier audits and the management of the Supplier Management program.

  • Manage (or assist with managing) actions from all audits through to implementation and closure.

  • Create (or review/update) QA specific processes in the QMS.

  • Execute QA processes listed on QMS such as CAPA, deviation management and compliance findings.

  • Assist other departments in ensuring the QMS is relevant to business needs.

  • Manage (or assist with) creating and improvement of tooling required to host the QMS.

  • Assist with Root Cause Analysis investigations across the organization.

Minimum Requirements/Qualifications:

  • At least 7 years Software Quality Assurance experience in a pharmaceutical aware environment

  • Degree in computing, science or related discipline

  • Experience of process design

  • Experience of software development methodologies

  • Experience of root cause analysis

  • Knowledge of GxP regulations, GAMP and 21 CFR Part 11

  • Basic computing skills including Microsoft applications (Visio and MS SharePoint an advantage)

  • Excellent oral and written communication skills

  • Influencing and negotiation skills

  • Ability to work independently or in a group setting

  • Up to 20% Travel

Non-Negotiable Hiring Criteria:

  • Quality Assurance experience in a pharmaceutical aware environment

  • Knowledge of process improvement techniques

  • Experience of software development methodologies

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at 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.