We anticipate the application window for this opening will close on - 28 May 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 seeking a Quality Engineer II who is passionate about ensuring product quality and regulatory compliance in support of innovative medical devices. In this role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment. In this role you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.  

 

This is an onsite role at the Danvers, MA location.  

 

As a Quality Engineer II, you will: 

• Support product and process quality for Class II/III medical devices in a regulated manufacturing environment 

• Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis 

• Perform risk assessments and support risk management documentation (FMEA, fault tree analysis) 

• Provide quality engineering support for design changes, process improvements, and product launches 

• Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.) 

• Analyze quality trends, monitor metrics, and recommend data-driven actions 

• Collaborate across functions (R&D, Manufacturing, Regulatory, and Supplier Quality) to ensure compliance and product integrity 

• Support audits and inspections (internal, supplier, and regulatory bodies) 

• Contribute to fostering a culture of inclusion, safety, and continuous learning 

 

Must Have: Minimum Qualifications 

• Bachelor’s degree AND minimum of 2 years of relevant experience OR 

• Advanced degree with 0 years of experience 

 
Nice to Have: Preferred Qualifications 

• 2+ years of relevant quality, manufacturing, or product development experience in a regulated industry (medical device preferred) 

• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems 

• Strong analytical, problem-solving, and effective communication skills  

• Strong interpersonal and influencing skills  

• Experience with CAPA, risk management tools, and statistical analysis 

• Lean, Six Sigma, or quality certifications (e.g., ASQ CQE) 

• Hands-on knowledge of root cause investigation and validation protocols 

• Experience working in an inclusive, cross-functional team setting 

 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description ar