Senior Quality Systems Auditor - remotely based in US or UK
Company InformationThermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. 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 and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
• Lead and/or manage audits and inspections.
• Help to develop the corporate internal auditing function, processes and procedures.
• Lead quality system audits to ensure the Global Quality Management System operates in a state of compliance and continuous improvement
• Perform audits across the Medical Devices organization, performing mock FDA audits and due diligence work where applicable.
• Document audit reports within specified time frames and generate audit corrective action requests as applicable
• Follow, interpret and create written Policies and Standard Operating Procedures (SOP's).
• Monitor non-conformances, perform trend analyses, and present findings
• Contribute to the development and improvement of audit program metrics
• Report systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR/Vigilance reports, audit reports and other relevant data
• Provide or communicate input to Corporate Risk Management and Global Trade Compliance
• Involvement in Corporate CAPA (Corrective and Preventative Action) projects
• Establish and maintain network of internal and external contacts for project collaboration
• Help to interpret and disseminate information on new or changing regulatory requirements
• Manage suppliers and vendors
• Minimum 10 years' experience with quality assurance or quality systems in a regulated (FDA) industry, applying quality system regulations and quality standards, and performing quality system audits
• Bachelor's degree required in Sciences program (Microbiology, Electrical Engineering, etc.)
• Certified Quality Auditor (CQA) certification required; Lead Assessor Certification Required
• Pharma auditing experienced preferred.
• 5+ years' experience in auditing for medical devices, drug and biologic engineering, etc.
• Demonstrated understanding of industry regulations, including detailed knowledge of FDA QSR's and ISO 13485
• Ability to work in a matrix environment
• Persuasive and able to lead through influence
• Excellent verbal and written communication skills
• Ability to operate and use computers
• Ability to handle conflict with confidence and integrity
• Must possess sound organizational skills, demonstrate attention to detail and an ability to multi-task
• Total Quality Management process experience
• ASQ Certification or Equivalent
• Project Management experience a plus
Non-Negotiable Hiring Criteria:
• Must be able to travel approximately 70% of the time
• Must be able to challenge the status quo, influence others and encourage collaboration to resolve issues
• Must be able to identify customer needs and issues and develop realistic solutions to meet the needs of the business
• Must be able to make rational, objective, and appropriate decisions relating to company needs