What are the responsibilities and job description for the Manager, Quality Control position at Thermo Fisher Scientific?
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Laboratory SettingJob 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.
