• Sr. Quality Engineer

    ThermoFisher Scientific (Austin, TX)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    Job Description

    As part of the Thermo Fisher Scientific team, you’ll find meaningful work that makes a positive impact on a global scale. Join colleagues who bring our Mission to life every day, enabling customers to make the world healthier, cleaner, and safer. We provide the resources and opportunities to grow careers while advancing science and solving some of the world’s toughest challenges—like protecting the environment, ensuring food safety, and finding cures for cancer.

     

    Discover Impactful Work

     

    As a **Sr. Quality Engineer** , you will establish and maintain robust Quality Systems aligned with ISO 13485, ISO 9001, FDA 21 CFR Part 820, USDA, IVDD, and IVDR requirements. You’ll help ensure compliance with internal and external standards while driving continuous improvement, process control, material efficiency, and successful new product introduction.

     

    A Day in the Life

    + Collaborate across departments to resolve issues from customer feedback or deviations by leading investigations, root cause analysis, and corrective actions, ensuring accurate documentation and closure.

    + Conduct management reviews, internal audits, quality assessments, and change processes; approve procedures and address deviations.

    + Review and support validation plans and records to confirm requirements are met and documentation is accurately archived.

    + Support NPI projects, ensuring design control requirements are implemented successfully.

    + Lead projects and meetings on product issues such as the Material Review Board and Change Control Board, while driving continuous process improvements.

    + Identify and champion continuous improvement opportunities, actively participating in practical process improvement (PPI) initiatives.

    + Assess facilities, personnel, and documentation to confirm compliance and quality.

    + Prepare clear and concise business communications including audit reports, gap assessments, customer letters, and meeting summaries.

    + Actively participate in internal, external, and regulatory audits and inspections.

    + Promote a culture of quality by mentoring colleagues and helping them apply policies and controls.

    + Provide leadership in planning and accomplishing activities as a resource and mentor to peers, without supervisory responsibilities.

    + Serve as a backup for other Quality roles and tackle additional responsibilities as needed.

     

    Keys to Success

    Education

    + Bachelor’s Degree in Biological Sciences, Engineering, or related field (advanced degree preferred).

    Experience

    + 3–5 years of Quality Assurance experience in a regulated manufacturing or ISO-qualified environment, complying to 21 CFR 820, 21 CFR 803, ISO 13485, ISO 9001, and IVDR.

    + Lead Auditor certification from an accredited agency.

    + Proven success leading product launches and compliance projects in a matrixed environment.

    Knowledge, Skills, Abilities

    + Advanced proficiency with Excel.

    + Strong analytical and critical thinking skills.

    + Proactive, self-motivated, and able to deliver results on time.

    + Outstanding attention to detail with a commitment to accuracy.

    + Ability to advise the business while interpreting and applying regulations.

    + Clear written and verbal communication skills with the ability to collaborate across functions.

    + Strong time management and prioritization abilities.

    Benefits

    We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

     

    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.