Senior Quality Engineer - Medical Device Job at Intellectt Inc, Palm Beach Gardens, FL

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  • Intellectt Inc
  • Palm Beach Gardens, FL

Job Description

Role: Senior Quality Engineer – Medical Device

Location: Palm Beach Gardens, FL (Preferred) or Raynham, MA

Duration: Contract

Job Summary:

We are seeking a Senior Quality Engineer with strong experience in manufacturing or service/repair environments to support global projects focused on optimizing service and repair operations. This role includes leading validation, quality compliance, and cross-functional project activities.

Must Have:

  • 8–10+ years of Quality Engineering experience
  • Experience in manufacturing or service & repair environments
  • Strong QMS knowledge
  • Experience with Equipment Validation and Process Validation
  • Experience in Commissioning/Qualification activities
  • Project management or leadership experience
  • Knowledge of ISO 13485
  • Strong communication and stakeholder interaction skills

Nice to Have:

  • Experience with product transfers , service/repair , supply chain , or NPI
  • J&J experience (preferred)
  • Lean Six Sigma Green/Black Belt , PMP , or ASQ certification
  • Master’s Degree in Engineering or related field

Key Responsibilities:

  • Lead quality activities for service and repair optimization projects
  • Support product transfers and decommissioning activities
  • Execute validation and qualification activities
  • Act as the Quality representative in cross-functional teams
  • Ensure compliance with ISO 13485 and internal quality standards

Job Tags

Contract work

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