Engineer I, Source Quality, Orthopedics

Johnson & Johnson Johnson & Johnson · Pharma · Warsaw, IN +1

This role is for an Engineer I in Source Quality within the Orthopedics division, focusing on managing external manufacturers and suppliers. Responsibilities include establishing quality expectations, implementing process controls, supporting product launches, conducting supplier visits, providing quality engineering support for non-conformances and validation, contributing to root cause investigations, and applying risk management tools. The role requires a Bachelor's degree in Engineering or a related scientific field and 0-2 years of experience. Preferred qualifications include experience in manufacturing processes, the medical device industry, Six Sigma/Lean, quality engineering, blueprint reading, FDA CFR Part 820, ISO 13485, and process validation.

What you'd actually do

  1. Provides quality engineering leadership in the management of select External Manufacturers, Direct Material, and Indirect material suppliers.
  2. Responsible for technical leadership in establishing quality expectations at the supplier.
  3. Implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, process performance metrics).
  4. Partner with product development teams to support successful launches at suppliers.
  5. Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO-13485 and other applicable standards.

Skills

Required

  • Bachelor's degree in Engineering or related Scientific focus
  • 0-2 years of related experience
  • Excellent problem solving and decision-making skills
  • Communication/Interpersonal skills and flexibility to enable resolution of technical situations

Nice to have

  • Relevant work, internship, or Co-Op experience
  • Experience or knowledge with manufacturing processes; machining, injection molding, additive manufacturing and/or electronics manufacturing
  • Medical Device and/or Pharmaceutical industry
  • Six Sigma, Lean, or ASQ Certification/training
  • Quality engineering experience
  • Experience with Blueprint reading/literacy including GD&T
  • Familiarity with inspection methods and techniques
  • Knowledge of FDA CFR Part 820 and ISO 13485
  • Experience with process validation