What are the responsibilities and job description for the Operational Excellence Leader position at Thermo Fisher Scientific?
Are you passionate about quality management? Do you have a strong background in quality systems and experience working with cross-functional teams? If so, we want to hear from you! At Thermo Fisher Scientific, we are seeking a Quality Management System Developer to join our team and assist with site-critical Deviation Management projects.
Responsibilities
- Track and Manage Deviations: Monitor deviation records, results, and associated procedures to ensure compliance with regulatory requirements.
- Create and Edit SOPs: Develop and refine Standard Operating Procedures (SOPs) to close Quality Management System (QMS) gaps and drive continuous improvement.
- Lead Deviation Management Activities: Manage CAPA timelines and lead deviation management activities within cross-functional teams to achieve operational excellence.
- Investigate and Analyze: Conduct root cause analysis (RCA) activities and share knowledge with department owners and leads to improve quality systems.
Requirements: To succeed in this role, you should have a Bachelor's degree or equivalent preferred but not required. Additionally, you should possess at least 2 years of quality management system experience and be familiar with FDA Quality Systems Regulations (21CFR820), International Quality System Standards (ISO13485), and various manufacturing processes and quality systems.
Preferred Skills
- Strong Communication Skills: You should have strong written and interpersonal communication skills to effectively interact and influence at all levels of the organization.
- Critical Thinking and Problem-Solving: You should be able to develop and implement procedures, perform investigative processes, and utilize critical thinking and problem-solving skills to drive continuous improvement.
- Technical Proficiency: Proficiency in Microsoft Office, Excel, Minitab, and statistical computer programs is essential for success in this role.
