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Senior Quality Assurance Engineer

1 month ago

North Haven, Connecticut, United States Entegee Full time
Job Summary

We are seeking a highly skilled Quality Assurance Engineer to support our quality standards and test validation processes in a medical or clinical environment. The ideal candidate will have a strong background in engineering, with a focus on quality assurance and validation.

Key Responsibilities:

  • Prioritize, review, and provide direction on test plans and reports
  • Ensure testing methods, sample sizes, and acceptance criteria align with design intent
  • Develop, modify, and apply quality standards for materials and products
  • Collaborate with engineering and manufacturing teams to maintain quality standards
  • Design and specify inspection and testing mechanisms
  • Conduct quality assurance tests and perform statistical analysis
  • Ensure corrective measures meet reliability standards and maintain compliant documentation
  • Support process and equipment validation efforts through established protocols

Requirements:

  • BS in Engineering (Electrical Engineering preferred)
  • Minimum 2 years of relevant experience
  • Six Sigma certification or experience
  • Experience in medical or clinical environments
  • Knowledge of validation processes (IQ/OQ/PQ)
  • Familiarity with corrective and preventive actions (CAPA/NCR)

Preferred Skills:

  • Statistical analysis expertise
  • Knowledge of test methods and equipment validation
  • Experience with process and equipment validation protocols (IQ/OQ/PQ/TMV/PD/DOE)

Benefits:

  • Competitive hourly rate: $35.00 to $40.00 per hour
  • Comprehensive benefits package, including medical, dental, vision, life insurance, short-term disability, and 401K plan
  • Opportunities for professional growth and development

Equal Opportunity Employer:

  • Entegee is an equal opportunity employer and welcomes applications from diverse candidates
  • We are committed to creating an inclusive and respectful work environment