Senior Quality Engineer - North Haven, CT
LocationNorth Haven, Connecticut, United States of America
Work modeon-site
Typefull-time
SenioritySenior
Experience2+ yrs
DepartmentOperations Quality
Company size10,000+ people
PostedOct 8, 2026 · 5d ago
Verified live23h ago
At a glanceSummarised by Seekless from the posting.
Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience
Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience
PhD
2+ years of experience executing process validation activities across the full validation lifecycle
We anticipate the application window for this opening will close on - 19 Oct 2026
About the company
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
The Surgical Sutures Manufacturing business within Surgical Innovations develops and manufactures critical medical device products used in surgical procedures worldwide. The Operations Quality team partners with manufacturing, engineering, and technical functions to ensure compliance, process capability, product quality, and continuous improvement across manufacturing operations.
This position is based in North Haven, Connecticut and requires an onsite work schedule five (5) days per week at the manufacturing facility. Minimal travel is expected.
As a Senior Quality Engineer, you will provide quality engineering support for manufacturing operations with a primary focus on process validation and quality system execution. This role partners closely with engineering and manufacturing teams to ensure compliant, effective, and sustainable manufacturing processes while driving product quality, process reliability, and regulatory compliance within a highly regulated medical device environment.
Primary Responsibilities
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Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
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Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
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Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
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Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
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Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
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Support qualification and validation of manufacturing equipment, processes, and test methods.
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Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
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Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.
Required Qualifications
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Bachelor’s degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master’s degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.
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2+ years of experience executing process validation activities across the full validation lifecycle.