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Sr Supplier Quality Engineer

Johnson & Johnson

DePuy Synthes seeks a Senior Supplier Quality Engineer to provide quality assurance leadership for contract manufacturers and raw material suppliers in Palm Beach Gardens, Florida. The role involves managing supplier compliance, non-conformities, process validations, and regulatory interactions across medical device production.

Responsibilities

  • Implement supplier quality strategy and manage non-conformities, CAPA, and supplier change requests
  • Oversee process validations, product evaluations, and supplier assessments at contract manufacturers
  • Support product investigations, quality agreements, and FDA/regulatory authority inspections
  • Lead quality projects including legacy reviews, remediation, and integration efforts
  • Collaborate with Quality, Engineering, R&D, Regulatory, and Sourcing departments on supplier issues

Requirements

  • Bachelor's degree in Engineering, Life Science, or related field
  • Minimum 2-4 years GMP and/or ISO regulated industry experience
  • Strong root cause analysis, communication, and problem-solving skills
  • Medical device and/or pharmaceutical industry experience preferred
  • FDA CFR Part 820 and/or ISO 13485 knowledge preferred
  • Six Sigma, Lean, or ASQ certification preferred
  • Fluency in English (oral and written) required
Vacancy posted 2 days ago
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