Manager Quality Control
Manager Quality Control
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Laboratory SettingJob Description
Join Thermo Fisher Scientific for impactful work innovative thinking and a customerfocused 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 youll 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 inhouse 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 crossfunctional and crosssite initiatives.
- Develop and implement an organizational plan for business sustainability risk mitigation and growth.
- Enable and promote a culture based on the Thermo Fisher 4I valves Integrity Intensity Innovation and Involvement.
Keys to Success:
Education
- Bachelors 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.
Required Experience:
Manager
Employment Type
Full-Time
