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Job ID :
62458BR
Location :
US - Kansas - Lenexa
:
Job Description
Senior Quality Engineer-Lenexa, KS

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Division

The Microbiology Division (MBD) develops, manufactures, supplies and supports solutions for the clinical diagnosis of infectious disease and the detection of bacterial contamination in the food and pharmaceutical industries. We serve public health and clinical laboratories, food companies and pharmaceutical laboratories with high quality products which include culture media, antimicrobial susceptibility testing and market-leading food safety molecular solutions. Our 2,000+ dedicated employees are focused on providing our customers with consistently exceptional service. Headquartered in Basingstoke, England with over 20 sites worldwide.

How Will You Make An Impact?

This role will lead in the implementation of quality assurances practices, process controls, change control and Corrective and Preventive Action activities. This position is embedded in the Operations Work Stream. The Sr. Quality Engineer will partner with Operations and is the primary point of contact for all Quality decisions affecting daily activities.

The Sr. Quality Engineer will approve investigations, deviations, change controls, validation protocols, validation reports, Operations SOP’s, and in-process controls. In addition they will evaluate and recommend process changes to improve the Value Stream performance and regulatory compliance.

The Sr. Quality Engineer is responsible for managing, and further developing Validation personnel and for organizing their work to be in alignment (or support) of the site Quality goals.
The individual selected for this role will act as an effective leader in promoting quality disciplines, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

What Will You Do?
  • Provide Quality review and approval of all investigations, deviations, change controls, validation protocols, validation reports, SOP’s, and in-process controls in support of the assigned Value Stream.
  • Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
  • Troubleshoot process issues. Lead inter-department teams in the resolution of process issues and quality problems.
  • Work as a member of new product introduction teams to provide quality input and capability analysis.
  • Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
  • Champion continuous improvement and the transition to a Lean Manufacturing Environment.
  • Drive quality management focus on productivity improvements throughout the business unit.
  • Work effectively as a member of cross-functional teams.
  • Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.
  • Drive Customer complaints to resolution; Serve as Quality Representative for all quality-related corrective/preventive actions within the Value Stream.
  • Assure that quality standards comply with division and departmental policies, national and international codes, and applicable safety requirements.
  • Leads PPI activities at the site including the facilitation of Kaizen events. Supports Operations and Quality team members on process improvement activities.
  • Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.
  • Manage Validation personnel reporting to the position to effectively develop, recruit, train, evaluate, motivate, delegate and monitor their work as it relates to the assigned value stream and Quality goals.
Education
  • Bachelor’s degree required in science, engineering or related field. Bachelors of Science Degree in Biology or Microbiology preferred.

Experience
  • A minimum of 5 years of experience in a regulated environment such as medical device, pharmaceutical, biotechnology or clinical.
  • Strong experience in process control and statistical techniques preferred.
  • Experience with GMP, EU Regulation, ISO 9001 or ISO 13485 preferred.
  • Experience with lean manufacturing practices. Green Belt or Black Belt certification a plus.
  • Previous experience leading a team preferred.

Knowledge, Skills and Abilities
  • Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma preferred.
  • Strong background in process control and statistical techniques preferred.
  • Medical device, GMP, EU Regulation or ISO 13485 background preferred.
  • Demonstrated working knowledge of compliance, quality and scientific principles a plus.
  • Must be a self-starter who can take general concepts and direction and produce desirable results.
  • Ability to prioritize multiple tasks function effectively in a global, multi-site organization.
  • Demonstrated ability to work effectively independently or as a member of a cross-functional team.
  • Strong working knowledge of various computer software, such as Mini-tab preferred.
  • Knowledge of qualification / validation (process, sterilization, software) requirements preferred.
  • Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
  • Excellent oral and written communication skills.
  • Strong leadership skills with the ability to challenge, influence, and build consensus.
  • Strong business acumen.
  • ASQ certification a plus.

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.


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.
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