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

Location/Division Specific Information

Philadelphia, PA Analytical Instruments Group/Digital Science Business Unit

How will you make an impact?

As part of the Quality team you will work to assure the quality objectives and the business requirements are met, building them into processes, ensuring compliance and driving improvement activities.

What will you do?

• Assume ‘QA’ role in SDLC (software development life cycle) projects with globally distributed teams

• Assume ‘QA’ role in infrastructure validation process

• Participate in regulatory body audits in person or remotely

• Conduct internal audits on global processes

• Assist in postal audits for regulated customers

• Assist in managing actions from all audits through to implementation and closure.

• Assist in creating/updating QA specific processes.

• Execute (or assist with) any other QA processes listed on QMS.

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

• Assist with tooling required to host QMS.

How will you get here?
Education

• Minimum required education: Degree in computing, science, or related discipline.

Experience

• Quality Assurance experience or experience of working with an SDLC (software development life cycle) role or experience working in a CSV (Computer System Validation) role.

• Experience in a pharmaceutical aware environment.

• Experience of an SDLC (software development life cycle) role in a SaaS environment.

• Experience of conducting or participating in audits.

Knowledge, Skills, Abilities

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

• Knowledge of data privacy, GDPR and ISO27001 or SOC 2.

• Knowledge of ISO9001:2015.

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

• Excellent oral and written communication skills.

• Ability to work independently or in a group setting

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.