Quality Engineer II

Johnson & Johnson Johnson & Johnson · Pharma · Palm Beach Gardens, FL +1

Quality Engineer II role at Johnson & Johnson focused on ensuring manufacturing areas meet good manufacturing practices and applicable standards. Responsibilities include supporting day-to-day manufacturing operations, nonconformance review, process verification and validation, risk assessments, inspection methodology, root cause investigations, and CAPA collaboration. The role also involves providing leadership in understanding QSR and ISO 13485 regulations, representing Quality during audits, implementing measurement systems for quality and reliability processes, and driving continuous improvement through Quality System enhancements.

What you'd actually do

  1. Ensure manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards.
  2. Support day-to-day manufacturing operations in areas such as nonconformance review and evaluation, process verification and validation, process risk assessments, inspection methodology and acceptance criteria for inspection sample plans, root cause investigations, and collaboration on corrective actions (CAPA).
  3. Provide leadership in understanding QSR and ISO 13485 regulations, both within the Quality team and across other departments, and help represent Quality during internal and external audits.
  4. Communicate effectively at all levels within the Quality department, as well as cross-functionally with teams such as R&D, Regulatory, Manufacturing, and Marketing.
  5. Implement measurement systems to monitor the effectiveness of quality and reliability processes, identifying, containing, correcting, and preventing defects, while demonstrating continuous improvement.
  6. Implement Quality System improvements to ensure compliance and support overall business objectives.

Skills

Required

  • Bachelor's degree in Industrial Engineering, Mechanical Engineering or related field
  • 2 years of experience in the job offered or in a Quality Engineer II-related occupation

What the JD emphasized

  • QSR and ISO 13485 regulations