Sr Quality Engineer

North Haven, Connecticut Quality Engineering 6 days ago

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Summary:
Senior Quality Engineer responsible for supporting new product development within the Surgical Innovations Business, focusing on risk management, reliability testing, and quality assurance.

Job Requirements:

  • BS in Engineering (EE preferred)
  • 4+ years of experience in engineering or quality roles
  • Experience with Risk Management ISO 14971
  • Medical/Clinical experience required
  • Design Failure Modes and Effects Analysis (DFMEA) development expertise
  • Understanding of Critical to Quality and Critical to Function (CTQ/CTF) from a Design, Part, Component, and Assembly perspective
  • Proficiency in Reliability Test Method Development, Strategy, and Statistical Analysis

Preferred Skills:

  • Knowledge of Electromagnetic Compatibility (EMC) Requirements, Testing, and Development

Job Responsibilities:

  • Support cross-functional teams for new product development
  • Conduct and lead DFMEA and Critical to Function Matrix activities
  • Implement risk management processes in compliance with ISO 14971 standards
  • Develop and review Design Verification and Validation Protocols and Reports
  • Create and execute Reliability Test Methods and related studies
  • Provide technical guidance to ensure compliance with regulatory and quality requirements
  • Collaborate on Mechanical and Electro-Mechanical design and testing activities
  • Participate in continuous improvement initiatives focused on product quality


Pay Details: $45.00 to $58.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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