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Job ID :
42719BR
Location :
US - Michigan - Kalamazoo
:
Job Description

Company Information

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $10.5 billion, we have more than 34,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike.

Position Summary:

  • Manage and continually improve all elements of the Quality Management System including the following processes: Customer Complaint Handling, Corrective and Preventive Action, Document Control Change Management, Supplier Management, Acceptance Activities including Incoming Inspection, Batch and Finished Product inspections, Device History Records, Non-Conforming Records, and the Quality Hold process, and Internal Audits

  • Drive reduction of customer complaints using solid investigation methodologies and root cause analysis expertise

  • Lead problem solving activities and implementation of permanent fix solutions

  • Coach, mentor, and develop quality personnel

  • Act as Quality Management Representative for the site

  • Build cross functional team collaborative culture

  • Track and monitor key performance indicators, create summary reports for the site metrics, and promote improvements based on data driven decisions

  • Provide training to the organization on QSR requirements, ISO 13485

  • Participate in Practical Process Improvement (PPI) Steering Committee

  • Lead and participate on Practical Process Improvement teams

  • Comply with all company policies and procedures (safety, regulatory, etc.)

Minimum Requirements/Qualifications:

  • Bachelor’s degree

  • Quality Systems Regulations experience required

  • Supervisor experience required

  • Experience in a manufacturing environment

  • Creative, analytical problem solving skills

  • Excellent communication and attention to detail

  • Problem solving and root cause analysis expertise

  • Ability to work independently and as part of a team

  • Must demonstrate strong organizational skills

  • Strong team player and leader with the ability to work with other functional leaders

  • Ability to handle critical timelines in a multi-task environment

  • Must demonstrate leadership skills

  • Proficient in MS applications (Excel, Word, Outlook)

  • ISO 13485 Lead Auditor Certification preferred

  • American Society for Quality certification preferred

  • Demonstrated experience as Six Sigma Black Belt or with other continuous improvement methodologies is preferred

  • Must be available to travel up to 5% of the time

    Non-Negotiable Hiring Criteria:

  • Bachelor’s degree

  • Quality Systems Regulations experience required

  • Supervisor experience required

  • Experience in a manufacturing environment

    *IND-SDG




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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