Qa Operations Lead

Johnson & Johnson Johnson & Johnson · Pharma · Yokneam, Haifa District, Israel

Lead Quality Assurance operations for new product introductions in the cardiovascular medical device sector, ensuring product and process stabilization, compatibility, and readiness for production. This role involves active participation in development teams, supporting transfer to production, analyzing quality trends, supporting key production processes (pFMEA, Control Plan, CTQ), and managing process validation/verification activities. Requires a BSc in Engineering or equivalent with Quality Assurance qualifications, practical knowledge of ISO13485, and experience in medical device companies.

What you'd actually do

  1. Establish and lead Quality activities for new product introduction to operation until the product/process stabilization
  2. Provide and communicate quality operation deliverables and inputs in early development stages and actively participate in development teams and serve as focal point from QA Operation, supporting the transfer to production activities
  3. Verifies product / Test equipment /process Compatibility and readiness for production
  4. Review and analyze quality trends with the operation team until new product/process stabilization
  5. Support robust key production processes ( pFMEA , Control Plan , CTQ )
  6. Manage Process validation/ Verification activities

Skills

Required

  • BSc in Engineering or Practical Engineering with Qualification in Quality Assurance (CQE, CQM or CQA)
  • Practical knowledge of ISO13485
  • Experience in medical system or medical device companies
  • Demonstrated knowledge of manufacturing principles and practices (such as SMT, wave, testing), and procedures
  • Experience with validations (IQ/OQ/PQ/TMV) and supplier management
  • Experience with Leading multidisciplinary project and processes
  • Project management
  • problem solving
  • Good communication skills, both verbal and written in English

Nice to have

  • Understanding of drawings, specifications, and electrical schemes

What the JD emphasized

  • ISO13485
  • validations (IQ/OQ/PQ/TMV)