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Senior Quality Engineer - Manufacturing – Base Salary 80k to 105k/year - Auburn, NY

Auburn, NY 13021

Industry: Manufacturing Job Number: 27777S123 Tag:

Job Description

Senior Quality Engineer - Manufacturing – Base Salary 80k to 105k/year – Auburn, NY

  • Our client, renowned for their innovative and trailblazing approach to shaping future products in the manufacturing industry, is seeking a Senior Quality Engineer to ensure product excellence and optimize manufacturing efficiency.
  • In this position, you'll leverage your expertise in manufacturing and software quality engineering to facilitate compliance with industry regulations and Quality Systems requirements while assisting internal stakeholders, customers, and suppliers.


  • Contribution to the development and execution of regulatory strategies for ongoing development projects, product transfers, and QMS-related matters.
  • Supervision of non-conformances, CAPA, complaints, validations, and quality events, ensuring alignment with company policies, international regulations, and guidance, as well as site-specific procedures and requirements.
  • Offer expertise in manufacturing and software quality engineering to R&D and Engineering teams, ensuring compliance with ISO, FDA, CMRD regulations, and Quality Systems requirements, including reviewing and approving product life cycle management activities.
  • Conduct statistical data analysis, review metrics, and propose enhancements.
  • Provide support for internal, external, customer, and supplier audit programs.
  • Enhance Quality Management System procedures to align with US and European quality strategies.
  • Lead or provide support for activities related to Safety and Risk Management.


  • Bachelor’s degree in a scientific, technical, or business field, along with 5+ years of experience in a  manufacturing facility
  • Experience in a medical device or other highly regulated industrial environment
  • Understanding of ISO 9001 required, ISO 13485 preferred
  • Demonstrated understanding and application of Six Sigma, Lean Principles and related methodologies 
  • Experience with QMS, validation and verification processes, root cause analysis
  • Ability to travel internationally between sites and to customers and suppliers (up to 20%)
  • Audit experience required


  • Base salary in the 80k to 105k/year range
  • Medical, Dental, Vision, 401k, Paid Time Off



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Additional Information

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Meet Your Recruiter

Laura McKenney
Professional Recruiter

Laura brings many years of Recruiting experience to the world class AllSearch Recruiting team.

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