We anticipate the application window for this opening will close on - 7 Jul 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

We are currently seeking a dynamic Senior Quality Engineer to join our Advanced Surgical Instruments team in North Haven, CT. 

 

This role is critical to day-to-day quality engineering (QE) support within our Advanced Surgical Instruments (ASI) Focus Factory. The ideal candidate will be supporting various products in Advanced Stapling. This role is critical for day-to-day support of the manufacturing of medical devices for clinical use and improvement initiatives to production cells in Advanced Stapling. Also, Investigation of critical defects and CAPA implementation will be crucial for success.  

 

As a Senior Quality Engineer, you will: 

• Provide hands-on, proactive quality engineering support within a dynamic manufacturing environment. 

• Support and lead validation activities for existing products and processes in Advanced Stapling. 

• Support defect investigation through execution of NCMR and/or CAPA 

• Partner with cross-functional teams to drive continuous improvement and ensure compliance with regulatory and internal standards. 

• Develop, modify, apply, and maintain quality standards and protocols for materials and products throughout the lifecycle—from raw materials to finished goods. 

• Collaborate with engineering and manufacturing teams to maintain and enhance quality systems. 

• Design and implement inspection methods, testing protocols, and measurement systems to ensure product integrity and regulatory compliance. 

• Conduct quality assurance assessments and statistical analyses to identify trends and recommend data-driven corrective and preventive actions. 

• Participate in cost-reduction initiatives, such as Zero Loss Inspection Optimization, to support operational efficiency without compromising product quality. 

• Document and track quality metrics and ensure traceable, compliant recordkeeping. 

 

Must Have: Minimum Qualifications 

• Bachelor’s Degree with a minimum of 4 years of relevant experience OR 

• Advanced degree with a minimum of 2 years of relevant experience  

 
Nice to Have: Preferred Qualifications 

• Knowledge of validation protocols (IQ/OQ/PQ), risk management, and root cause analysis tools. 

• Experience with statistical methods, SPC, and quality tools such as FMEA, CAPA, or DOE. 

• Excellent communication, collaboration, and problem-solving skills. 

• Experience in a regulated industry (e.g., medical device, pharmaceutical, aerospace). 

• Proficiency in FDA and ISO 13485/9001 quality systems regulations and standards. 

• Green Belt or Black Belt certification in Six Sigma or similar methodologies. 

• Experience with data analysis platforms and digital quality systems.