Quality Engineer, Depuy Synthes

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

Quality Engineer for DePuy Synthes (Johnson & Johnson) in Palm Beach Gardens, FL. Supports on-site manufacturing, ensuring compliance with GMP, ISO, and other standards. Focuses on New Product Introduction and Value Improvement projects. Responsibilities include managing non-conformances, CAPA records, risk assessments, product/process complaints, and conducting audits. Requires a Bachelor's degree, 1-2 years of relevant experience in regulated industries and manufacturing, and knowledge of risk management standards (MDSAP, MDD, MDR, FDA, ISO).

What you'd actually do

  1. Provides overall quality assurance leadership of on-site manufacturing areas.
  2. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards.
  3. This position is focused on the support of New Product Introduction and Value Improvement projects implementation to the PBG Site.
  4. Provides comprehensive quality support for daily manufacturing activity.
  5. Manages the initiation, containment, investigation, disposition and closure of Non-Conformances in the PBG and WPB MAKE Sites.

Skills

Required

  • Bachelor's degree
  • 1-2 years of relevant work experience or internships
  • Experience working in regulated industries
  • Experience working in manufacturing/operations
  • In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)
  • Experience and a proven track record of implementing appropriate risk mitigation

Nice to have

  • Degrees in Engineering, Life Science, or related field
  • Advanced knowledge of Six Sigma methodologies
  • Understanding of the NPI (New Product Introduction) process

What the JD emphasized

  • regulated industries
  • product/process Risk Management
  • risk mitigation