Quality Engineer

Michael Page; Danbury (CT); On-site; USD 70,000 - 100,000; Full time

Job summary

MPI is seeking a Quality Engineer in Danbury, CT to lead quality engineering activities for implantable medical devices, driving risk management, investigations, CAPAs, and process controls in a highly regulated environment.

You will develop validation protocols, establish QC plans and SPC methods, collaborate with customers and suppliers, and ensure ISO 13485 and FDA 21 CFR 820 compliance while supporting continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical field.
• Experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and regulated quality systems.
• Experience with validations, risk management, CAPA investigations, and quality documentation.
• Strong statistical analysis skills, including experience with Minitab or similar software.
• Excellent technical writing, communication, and project leadership abilities.

Responsibilities

• Lead quality engineering activities for new product introductions, process improvements, and manufacturing optimization projects.
• Drive root cause investigations, CAPAs, nonconformance resolution, and risk mitigation activities using advanced quality tools.
• Develop and execute validation protocols, test methods, equipment qualifications, and process validations.
• Establish and maintain quality control plans, SPC programs, inspection methodologies, and process monitoring systems.
• Partner with customers, suppliers, and internal stakeholders to resolve quality issues and ensure regulatory compliance.
• Support ISO 13485 and FDA-regulated operations through audits, documentation, training, and continuous improvement initiatives.

Skills

Quality Engineering

Risk management

CAPA investigations

Statistical analysis

Technical writing

Project leadership

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

This is a Quality Engineering role supporting the development, validation, and continuous improvement of implantable medical device manufacturing processes. The Quality Engineer will serve as a technical expert, leading risk management, investigations, validations, process controls, and customer quality activities across a highly regulated environment.

Our client is a rapidly growing advanced manufacturing organization that partners with leading medical technology companies to develop innovative products that improve patient outcomes worldwide. With significant recent investments, expanded capabilities, and a strong culture of engineering excellence, they offer professionals the opportunity to work on cutting-edge technologies in a highly collaborative environment.

Description

• Lead quality engineering activities for new product introductions, process improvements, and manufacturing optimization projects.
• Drive root cause investigations, CAPAs, nonconformance resolution, and risk mitigation activities using advanced quality tools.
• Develop and execute validation protocols, test methods, equipment qualifications, and process validations.
• Establish and maintain quality control plans, SPC programs, inspection methodologies, and process monitoring systems.
• Partner with customers, suppliers, and internal stakeholders to resolve quality issues and ensure regulatory compliance.
• Support ISO 13485 and FDA-regulated operations through audits, documentation, training, and continuous improvement initiatives.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Profile

A successful Quality Engineer should have:

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical field.
• Experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and regulated quality systems.
• Experience with validations, risk management, CAPA investigations, and quality documentation.
• Strong statistical analysis skills, including experience with Minitab or similar software.
• Excellent technical writing, communication, and project leadership abilities.

Job Offer

• Salary range of $70,000 to $100,000.
• Work directly on implantable and life-saving medical technologies.
• Join a recently expanded manufacturing center with significant investment and growth.
• Gain exposure to structural heart, neurovascular, and minimally invasive device programs.
• Lead impactful quality initiatives with high visibility across operations and engineering.
• Enjoy long-term career growth opportunities within a global medical device manufacturing organization.

This is a Quality Engineering role supporting the development, validation, and continuous improvement of implantable medical device manufacturing processes. The Quality Engineer will serve as a technical expert, leading risk management, investigations, validations, process controls, and customer quality activities across a highly regulated environment.

Our client is a rapidly growing advanced manufacturing organization that partners with leading medical technology companies to develop innovative products that improve patient outcomes worldwide. With significant recent investments, expanded capabilities, and a strong culture of engineering excellence, they offer professionals the opportunity to work on cutting-edge technologies in a highly collaborative environment.

Description

• Lead quality engineering activities for new product introductions, process improvements, and manufacturing optimization projects.
• Drive root cause investigations, CAPAs, nonconformance resolution, and risk mitigation activities using advanced quality tools.
• Develop and execute validation protocols, test methods, equipment qualifications, and process validations.
• Establish and maintain quality control plans, SPC programs, inspection methodologies, and process monitoring systems.
• Partner with customers, suppliers, and internal stakeholders to resolve quality issues and ensure regulatory compliance.
• Support ISO 13485 and FDA-regulated operations through audits, documentation, training, and continuous improvement initiatives.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Profile

A successful Quality Engineer should have:

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical field.
• Experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and regulated quality systems.
• Experience with validations, risk management, CAPA investigations, and quality documentation.
• Strong statistical analysis skills, including experience with Minitab or similar software.
• Excellent technical writing, communication, and project leadership abilities.

Job Offer

• Salary range of $70,000 to $100,000.
• Work directly on implantable and life-saving medical technologies.
• Join a recently expanded manufacturing center with significant investment and growth.
• Gain exposure to structural heart, neurovascular, and minimally invasive device programs.
• Lead impactful quality initiatives with high visibility across operations and engineering.
• Enjoy long-term career growth opportunities within a global medical device manufacturing organization.

Desired Skills and Experience

• B.S. Degree
• Experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and regulated quality systems.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.