• 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
This position has not been approved for Relocation Assistance.