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Thermo Fisher Scientific Quality Systems Specialist in Lenexa, Kansas

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Quality Systems Specialist will lead in the implementation of quality assurances practices, process control, change control, and Corrective and Preventive Action activities. This position is part of the Quality Systems team. The Quality Systems Specialist will partner with supply chain and facilities/maintenance and is the primary point of contact for all Quality decisions affecting daily activities. The Quality Systems Specialist will approve investigations, deviations, change controls, and in-process control improvements. In addition they will evaluate and recommend process changes to improve performance and regulatory compliance. The Quality Systems Specialist 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?

  • Develop, maintain and monitor programs for in compliance with the Quality Systems Regulations and internal procedures.

  • Maintain the Vendor Approval, Raw Material Specifications, Change Control, Corrective and Preventive Action, and Audit programs.

  • Participate as team leader in Vendor, Customer, and External Audits.

  • Create and review Quality Agreements with other ThermoFisher Scientific locations and customers.

  • Oversee daily internal audit/inspection effort to ensure a formally established and documented audit program is maintained.

  • Coordinate employee activities for support position/s (QS Technician/s) including daily task assignments as well as recommendations to QS Manager concerning disciplinary action, performance appraisals, and departmental staffing for the support positions.

  • Provide Quality input to all investigations, deviations, change controls, SOP’s, and in-process controls in support of the assigned Value Stream(s).

  • 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.

  • 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.

  • Drive Customer complaints to resolution; Serve as Quality Representative for all quality-related corrective/preventive actions.

  • Lead 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.

How will you get here?

  • Bachelor’s Degree in a science, or related field.

  • 2 years of experience in a regulated environment such as medical device, pharmaceutical, biotechnology or clinical is highly preferred.

  • Excellent oral and written communication skills.

  • Must be able to work independently, by taking general concepts and direction to produce desirable compliant outcomes.

  • Ability to prioritize multiple tasks and to function effectively in a global, multi-site organization.

  • Demonstrated ability to inspire and lead cross-functional teams.

  • Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment

  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.

  • Listen to and follow verbal and written instructions given in the English language.

  • Ability to travel up to 10%.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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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