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Principal Engineer eQSM Support

Columbus, OH 43235

Posted: 11/30/2022 Employment Type: Contract Job Category: Engineering Job Number: 529353 Is job remote?: Yes Country: United States

Job Description

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.  Specifically, the Principal Engineer, Supplier Quality role entails:
  • Administers the Supplier Corrective Action Request (SCAR) process as the single Point of Contact subject matter expert for the NA/EMEA/LATAM regions.  This role’s main responsibilities are as follows:
    • Medical Segment SCAR Oversight
      • Provides Medical Segment process oversight by answering procedure related questions and training to new users
      • Collects overall process execution feedback and updates the SCAR Standard Operating Procedure as needed
      • Manages SCAR tracking and trending, establishes metrics, and reports metrics to leadership
    • External Manufacturing SCAR Coordinator
      • Review and approve new SCAR requests
      • Work with SCAR Owners to ensure SCAR is compliant, adequate, accurate, and completed on time
    • External Manufacturing NA/EMEA/LATAM supplier quality regions NC Coordination
      • NC Coordinator agent
      • Provide customer support by answering questions and providing training
      • Review and approve new NC
      • Work with NC Owners to ensure NC is compliant, adequate, accurate, and completed on time
      • Monitor NC and enter in tracking files
      • Prepare NC metric categories data for monthly Monitoring Meetings
      • Track NC data and review for trends
    • External Manufacturing NA/EMEA/LATAM SCAR Performance Management
      • SCAR Review Board process lead agent, execute SCAR procedure revision updates, and obtain necessary approvals
      • Provide customer support to process users
      • Conduct SCAR Review Board meetings
      • Manage SCAR tracker and gather supplier performance data from business partners
      • Monitor SCAR Review Board actions
      • Track SCAR data and review for trends
  • Collaborating with team members to improve corporate supplier qualification procedures and process to improve supplier oversight
  • Ensure supplier quality systems adhere to all applicable regulations and standards
  • Collaborate with team members to improve corporate supplier qualification procedures and documents to improve supplier oversight
  • Support assigned continuous improvement projects
  • Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products
  • Support applicable internal corrective actions to assure effectiveness and avoid repeat issues
  • Ensure supplier quality systems adhere to all applicable regulations and standards

  • Advance knowledge of business platforms and processes Veeva, SmartSolve, Agile PLM, Adobe EchoSign, Tableau
  • Ability to work with and lead cross-functional teams, including production, quality, engineering and materials and sourcing to understand respective impact of process changes or improvements.
  • Organized and resourceful with attention to detail and ability to execute on assigned project plans
  • Clear written and verbal communication skills to drive clear alignment of company and department goals
  • The ability to take responsibility for their own professional development and implement new approaches to doing things.
  • Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations

  • Bachelors in related field, or equivalent work experience, preferred
  • 4+ years experience in related field, preferred

What is expected of you and others at this level
  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
  • May contribute to the development of policies and procedures
  • Works on complex projects of large scope
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

0-10% travel is anticipated

*CO/NYC candidates might not be considered
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