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
