Quality Engineer - Medical Device Manufacturing - Hudson, NH
Company: Michael Page
Location: Hudson
Posted on: June 25, 2025
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Job Description:
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.
Keywords: Michael Page, Methuen , Quality Engineer - Medical Device Manufacturing - Hudson, NH, Engineering , Hudson, Massachusetts
