Senior Quality Engineer - North Haven, CT

Medtronic

Actively hiring
North Haven, CT Posted 10 days ago $98,400–$147,600 / year
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At a glance

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TL;DR

The Senior Quality Engineer role at Medtronic’s Surgical Innovations group in North Haven, CT, involves ensuring high standards of quality and compliance in medical device manufacturing. This key position collaborates cross-functionally to enhance product reliability and optimize processes while maintaining regulatory compliance. Day-to-day responsibilities include developing and modifying quality protocols, collaborating with engineering and manufacturing teams, implementing inspection methods, conducting quality assurance tests, and performing statistical analysis. Ideal candidates have a Bachelor’s or advanced degree in Engineering or Science, along with experience in process validation, root cause investigations, and continuous improvement tools like Minitab. The role requires expertise in FDA-regulated environments, knowledge of CFR requirements, and the ability to mentor engineers and work effectively across teams.

Skills

Minitab FDA regulations CFR requirements Engineering drawings Machining Chemical processing Packaging Sterilization Quality standards Process validation Root cause analysis CAPA development Nonconforming material management Statistical analysis Cross-functional collaboration Continuous improvement Manufacturing processes Regulated environments

What you'll do

  • Develop and modify quality standards and protocols for manufacturing processes.
  • Design inspection methods and equipment to ensure product precision and accuracy.
  • Conduct quality assurance tests and perform statistical analysis on products.
  • Ensure corrective measures meet reliability standards and documentation is compliant.
  • Lead root cause investigations, CAPA development, and manage nonconforming material activities.

What we're looking for

  • Bachelor’s Degree in Engineering, Science or technical field with 4+ years of relevant experience.
  • Develop and implement quality standards and protocols for manufacturing processes.
  • Collaborate with engineering and manufacturing teams to ensure regulatory compliance.
  • Conduct root cause investigations and manage Corrective Action/Preventive Action (CAPA) activities.
  • Proficient in statistical analysis tools like Minitab for data-driven decision making.

Employer

About Medtronic

Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.

Medtronic currently has 52 open roles on FindRole.

Listed pay typically runs $124,800–$187,200 across 51 roles with salary data.

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