Quality Engineer II Exempt

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profile Job Location:

North Haven, CT - USA

profile Monthly Salary: Not Disclosed
Posted on: 1 hour ago
Vacancies: 1 Vacancy

Job Summary

Job Title: Quality Engineer
Client: Medical Device Manufacturing Industry
Duration: 2 Years (Possible Extension)
Location: North Haven CT 06473
Shift: 1st shift Hybrid (4 days onsite 1 day remote)

Key Responsibilities

  • Perform risk assessments and design change quality reviews
  • Investigate product quality issues and root causes
  • Review and approve engineering change documentation
  • Develop and maintain quality standards and protocols
  • Perform inspections testing and statistical analysis
  • Ensure corrective actions meet compliance and reliability standards
  • Support continuous improvement projects
  • Collaborate with engineering and manufacturing teams

Must Have

  • Technical writing
  • Data analysis
  • Project management
  • Medical device industry experience(Pharma Bio-tech etc)
  • Risk assessment and quality review experience
  • Root cause investigation skills
  • Quality documentation and compliance knowledge

Nice to Have

  • DFMEA and risk management file experience
  • Product design and reliability knowledge
  • Cross-functional project experience
  • Mentoring or leadership exposure
  • Continuous improvement project experience

Role Scope

  • Support full product lifecycle (design to post-market)
  • Work on CSI stapling product portfolio
  • Manage multiple projects in parallel
  • Individual contributor role
  • May guide junior team members

Education & Experience

  • Bachelors degree required
  • 2 years relevant experience
  • Advanced degree accepted with 0 years experience

#ZR

Job Title: Quality Engineer Client: Medical Device Manufacturing Industry Duration: 2 Years (Possible Extension) Location: North Haven CT 06473 Shift: 1st shift Hybrid (4 days onsite 1 day remote) Key Responsibilities Perform risk assessments and design change quality reviews Investigate prod...
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Key Skills

  • APQP
  • Quality Assurance
  • Six Sigma
  • ISO 9001
  • PPAP
  • Minitab
  • Root cause Analysis
  • ISO 13485
  • Quality Systems
  • Quality Management
  • As9100
  • Manufacturing