Quality Engineer – Medical Device Manufacturing – Hudson, NH Position Available In Middlesex, Massachusetts

Job Description:

The Quality Engineer, medical device manufacturing, will work toimprove the quality of products and processes while operating in aculture highly receptive to quality. You will have the opportunityto support and provide guidance to ensure adherence to processesand procedures that maintain safety, efficacy, and compliance withapplicable standards and regulations onsite at out Hudson, NHfacility. Client Details My client is a small medical devicemanufacturer specializing in advanced diagnostic equipment usedduring surgical procedures. Their team mainly consists ofmanufacturing staff, quality inspectors, and engineers focused onprocess improvement. They have both domestic and internationaloperations and prioritize precision and quality in their products.

Description The Quality Engineer, Medical Device Manufacturing,will:

Conduct compliance assessments and ensure adherence toquality and regulatory requirements. Participate in qualityinitiatives and compliance improvement projects. Author and reviseoperating procedures, test/inspection protocols, and reports.

Perform root cause analysis, impact assessments, and implementcorrective and preventive actions (CAPA). Analyze statistical dataand trends to support yield improvements, complaint reduction, andscrap minimization. Contribute to continual process improvementthrough active participation in site projects. Facilitate riskassessments and FMEAs for new product introductions, ensuringadequate quality and safety controls. Create, maintain, andremediate Design History Files and Risk Management documentation.

Perform supplier and internal change evaluations and supportproduct quality reviews. Manage customer notifications, fieldactions, and other post-market activities as needed. Support newproduct development to ensure smooth transfer from development toproduction. Assist with broader Quality Management Systemactivities as required. Profile 3-5 years’ quality experience,including at least one role as a Quality Engineer in a medicaldevice company (design or production). Bachelor’s degree inengineering or a related field. Knowledge and experience with ClassII medical devices and

ISO 13485

quality standards. Ability to workindependently and be fully onsite on our Hudson, NH facility JobOffer Annual discretionary holiday bonus based on companyperformance and leadership decision Opportunity to work in acollaborative environment with diverse projects andcross-functional teamwork Flexibility in work hours beyond thetypical 9-to-5 schedule Growing company backed by private equityinvestment, fueling expansion and capital improvements Chance tocontribute to building and developing new teams within theorganization Company recently expanded physical space toaccommodate growth and new initiatives MPI does not discriminate onthe basis of race, color, religion, sex, sexual orientation, genderidentity or expression, national origin, age, disability, veteranstatus, marital status, or based on an individual’s status in anygroup 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.