What are the responsibilities and job description for the Senior Quality Engineer – Medical Device position at Intellectt Inc?
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