Manager, Quality Control at Thermo Fisher Scientific in Lenexa, Kansas

Job Description:

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.

• Bachelor's degree required

• 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

• 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.