Failure Investigation Team Lead

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

This role is a Failure Investigation Team Lead within the Quality Engineering department for a medical device company. The primary responsibilities include leading a team to conduct post-market investigations of FDA-approved medical devices, supporting CAPAs, and improving product quality and reliability through root cause analysis and establishing failure analysis techniques. The role requires a Bachelor's degree in a related scientific discipline, experience in mechanical engineering, knowledge of statistical tools, and understanding of manufacturing processes. Medical device experience and Green Belt certification are preferred.

What you'd actually do

  1. Responsible for identifying and researching failures to improve product quality and reliability.
  2. Lead projects by developing a project plan and schedule and by adhering to design controls
  3. Lead Technical Discussions with team.
  4. Responsible for timely complaint closure across the team.
  5. Responsible for leading training and onboarding of new team members

Skills

Required

  • Bachelor's degree in Mechanical Engineering or related scientific discipline
  • 3+ years of related experience in mechanical engineering
  • Knowledge of statistical tools and analytical software such as, MiniTab & Matlab
  • Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives
  • Working knowledge of applicable manufacturing processes such as injection molding, extrusion and fabrication.
  • Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
  • Ability to exercise judgment methods, techniques and evaluation criteria for obtaining results.
  • Execute tasks in a timely manner without direct supervision
  • Ability to prioritize tasks and effectively manage time
  • Proficient Microsoft Office Suite

Nice to have

  • MS preferred
  • Medical Device experience preferred
  • Green Belt preferred
  • Corrective and Preventive Action (CAPA)
  • Customer Centricity
  • Data Savvy
  • Developing Others
  • Document Management
  • Execution Focus
  • Good Automated Manufacturing Practice (GAMP)
  • Inclusive Leadership
  • Leadership
  • Lean Supply Chain Management
  • Problem Solving
  • Process Improvements
  • Quality Control (QC)
  • Quality Services
  • Quality Standards
  • Quality Systems Documentation
  • Quality Validation
  • Science, Technology, Engineering, and Math (STEM) Application

What the JD emphasized

  • Must have knowledge of statistical tools and analytical software such as, MiniTab & Matlab
  • Must have a working knowledge of applicable manufacturing processes such as injection molding, extrusion and fabrication.
  • Must be proficient Microsoft Office Suite