Job Description

Work Schedule

Environmental Conditions

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.

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