• Manager, Quality Control

    ThermoFisher Scientific (Lenexa, KS)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Laboratory Setting

    Job Description

    Join Thermo Fisher Scientific for impactful work, innovative thinking, and a customer-focused culture.

     

    Location/Division Specific Information

     

    At Lenexa, you will be a key member of the Quality leadership team supporting manufacturing of in vitro diagnostics and laboratory reference materials. As QC manager, you’ll contribute to a leadership team focused on ensuring our customers receive the products needed to achieve their scientific goals.

    Discover Impactful Work:

    Lead a team in overseeing, testing, and evaluating products to meet industry standards and customer needs.

     

    A day in the Life:

    + Lead the Quality Control team under the Director of Quality, managing raw materials, product testing, and process improvement in two labs.

    + Help redesign the vision for the QC team based on our evolving business while maintaining laboratory budget to plan.

    + Understand Customer needs and Operational requirements essential for delivering quality product on time.

    + Carry out in-house processes and procedures maintaining compliance to 21 CFR 820, ISO 13485, and IVDR standards.

    + Provide guidance and expertise to workstream QC Operations personnel by coaching, mentoring, developing people, and by encouraging a culture of learning.

    + Guide the team through (OOS) Out of Specification investigations and general troubleshooting with an effort towards timely resolutions.

    + Establish QC metrics, data trending, and drive actions for department improvements.

    + Apply leadership skills in maintaining and supporting a safe and quality culture.

    + Partner with cross functional team members to drive and complete critical quality, cross-functional and cross-site initiatives.

    + Develop and implement an organizational plan for business sustainability, risk mitigation and growth.

    + Enable and promote a culture based on the Thermo Fisher 4-I valves – Integrity, Intensity, Innovation and Involvement.

    Keys to Success:

    Education

    + Bachelor’s degree required

    Experience

    + A minimum of 8 years of experience in a regulated industry (medical device, pharmaceutical, or food preferred)

    + 5+ years of experience in direct leadership positions

    + Experience leading, developing a team in a dynamic and growing business

    + Experience with internal, external, and customer audits

    + Experience working in a regulated environment

    Knowledge, Skills, Abilities

    + Able to develop and guide a team to build strategy while encouraging a positive environment.

    + Experience with CFR compliance, ISO 13485, ISO 17025, ISO 17034 requirements preferred.

    + Quality Control experience in medical device, pharmaceutical, or biotech manufacturing plants preferred.

    + Flexibility to adapt to a dynamic environment and lead activities to meet the needs of the business while upholding a focus on quality.

    + Technical skills and initiative to develop effective and constructive solutions to problems.

    + Proficient in continuous process improvement practices such as Kaizen, Gemba, 3P, 5S, Standard Work and others.

    + Good understanding of laboratory test methods according to CLSI, EUCAST, and USP/EP preferred.

     

    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.