Staff Engineer

We are seeking a highly skilled Staff Engineer to join our Global Supplier Quality Development & Process Validation team. As a key member of our team, you will be responsible for ensuring the timely completion of process validation requirements for new products and life cycle change management projects with suppliers.

• Ensure supplier process validation requirements are communicated, completed, and verified for each responsible group.
• Drive continuous improvement in supplier quality processes through data analysis and identification of areas for improvement.
• Perform for-cause audits to determine root cause and drive CAPAs while supporting the site supplier quality teams.
• Provide support to sites by leading critical Supplier Quality related issues which may require supplier visits and audits.
• Review and approve executed qualification documentation (IQ/OQ/PQ) with suppliers for new product and LCM projects.
• Develop and promote the right behaviors to sustain a culture of continuous improvement necessary to support both short- and long-term business objectives.
• Support the supplier consolidation initiative.
• Provide and develop training on the Process Validation concepts to the team and organization, as needed.
• Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, 21 CFR Part 11 & IQ/OQ/PQ.

• Bachelor's degree or equivalent with 10+ years of experience, master's degree with 8+ years of experience, Doctoral degree with 5+ years of experience in manufacturing engineering, Mechanical Engineering, Industrial Engineering or Sciences.
• Minimum 8 years of experience in quality or manufacturing with bachelor's degree.
• Strong experience in process validation and component qualification - IQ/OQ/PQ and data analytics.
• Medical Device or Pharmaceutical experience is required.
• Experience or knowledge of ISO 9001 and ISO 13485 requirements preferred.
• Travel up to 25% with a possibility of international travel.
• Experience in FDA and other regulatory controlled environment.
• Strong collaboration skills and experience working in a matrix environment.
• Ability to read and understand technical and statistical documents.
• Ability to interface with technical and non-technical personnel.
• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.