Qa Ops Platform Lead

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

The QA Operation Platform Lead is responsible for end-to-end quality management for product families, from supplier selection and qualification through transfer to production and maintaining supplier and process control during the product lifecycle. This role supports quality-related activities, manages process validation, supports change control, and leads improvement plans with suppliers.

What you'd actually do

  1. Supporting quality-related activities throughout transfer to production and production.
  2. Manage Process validation/ Verification activities including Suppliers guidance with Biosense process validation requirements, planning, execution, monitoring, reporting and approval
  3. Support change control activities through production
  4. Support robust key production processes (CTXs cascading, monitoring tools, PFMEA Activities reduce human error etc.)
  5. Nonconformance & CAPA investigations

Skills

Required

  • BSc or Qualification in Quality Assurance (CQE, CQM or CQA)
  • Practical knowledge of ISO13485
  • experience with medical device electromechanics manufacturing companies
  • Demonstrated knowledge of manufacturing principles, practices and procedures
  • Ability to lead multidisciplinary projects and processes
  • Good communication skills, both verbal and written in English.
  • Strong interpersonal relations
  • Analytical and problem-solving skills and ability to learn
  • Sense of urgency
  • Ability to communicate effectively with a diverse clientele base and work cooperatively with coworkers

Nice to have

  • Business Alignment
  • Business Behavior
  • Coaching
  • Compliance Management
  • Continuous Improvement
  • Data Analysis
  • Detail-Oriented
  • Goal Attainment
  • Human-Centered Design
  • Internal Controls
  • Issue Escalation
  • Problem Solving
  • Process Oriented
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Standards

What the JD emphasized

  • ISO13485
  • medical device electromechanics manufacturing companies