Quality Engineer - Medical Device Manufacturing - Hudson, NH

The Quality Engineer, medical device manufacturing, will work to improve the quality of products and processes while operating in a culture highly receptive to quality. You will have the opportunity to support and provide guidance to ensure adherence to processes and procedures that maintain safety, efficacy, and compliance with applicable standards and regulations onsite at out Hudson, NH facility.

Client Details

My client is a small medical device manufacturer specializing in advanced diagnostic equipment used during surgical procedures. Their team mainly consists of manufacturing staff, quality inspectors, and engineers focused on process improvement. They have both domestic and international operations and prioritize precision and quality in their products.

Description

The Quality Engineer, Medical Device Manufacturing, will:

• Conduct compliance assessments and ensure adherence to quality and regulatory requirements.
• Participate in quality initiatives and compliance improvement projects.
• Author and revise operating procedures, test/inspection protocols, and reports.
• Perform root cause analysis, impact assessments, and implement corrective and preventive actions (CAPA).
• Analyze statistical data and trends to support yield improvements, complaint reduction, and scrap minimization.
• Contribute to continual process improvement through active participation in site projects.
• Facilitate risk assessments and FMEAs for new product introductions, ensuring adequate quality and safety controls.
• Create, maintain, and remediate Design History Files and Risk Management documentation.
• Perform supplier and internal change evaluations and support product quality reviews.
• Manage customer notifications, field actions, and other post-market activities as needed.
• Support new product development to ensure smooth transfer from development to production.
• Assist with broader Quality Management System activities as required.

Profile

• 3-5 years' quality experience, including at least one role as a Quality Engineer in a medical device company (design or production).
• Bachelor's degree in engineering or a related field.
• Knowledge and experience with Class II medical devices and ISO 13485 quality standards.
• Ability to work independently and be fully onsite on our Hudson, NH facility

Job Offer

• Annual discretionary holiday bonus based on company performance and leadership decision
• Opportunity to work in a collaborative environment with diverse projects and cross-functional teamwork
• Flexibility in work hours beyond the typical 9-to-5 schedule
• Growing company backed by private equity investment, fueling expansion and capital improvements
• Chance to contribute to building and developing new teams within the organization
• Company recently expanded physical space to accommodate growth and new 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.