Quality Engineer- Medical Device-Hudson, NH

• Fully Onsite
• Class 2

About Our Client
A small medical device manufacturer specializing in intraoperative and transcutaneous Doppler systems-hand-held ultrasound tools used during surgery to assess blood flow. The company produces FDA Class II devices for the U.S. market and Class III devices for international distribution, with a lean manufacturing team making up the majority of its 50-person workforce.
Job Description

• Assigned to moderately to highly complex processes and projects; conduct compliance assessments and ensure alignment with applicable quality and regulatory requirements.
• Participate in cross-functional teams focused on quality initiatives and compliance improvements.
• Draft and revise standard operating procedures, test methods, inspection protocols, and technical reports.
• Conduct impact assessments, root cause analyses, and implement corrective and preventive actions (CAPA) as needed.
• Analyze and interpret quality and performance data (e.g., yield, CAPA trends, complaints, scrap) to identify improvement opportunities.
• Support continuous process improvement by contributing to site-wide quality and efficiency projects.
• Lead or facilitate risk assessments and FMEAs for new product introductions and ongoing quality oversight activities.
• Develop, maintain, or remediate Design History Files (DHF) and Risk Management Files (RMF) to ensure compliance and product integrity.
• Evaluate supplier and internal changes; support product quality reviews, customer notifications, and field action activities.
• Collaborate on new product development efforts to ensure smooth transition from design to manufacturing.
• Provide support across various Quality Management System (QMS) activities as needed.
• Perform additional duties as assigned to meet team and organizational goals.

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.
The Successful Applicant
At least 1 prior role in a medical device company as a QE (design or production)
What's on Offer
Unique Selling Points / Growth Opportunities:

• High level of cross-functional collaboration with opportunities to wear many hats and contribute to diverse projects.
• Company size offers flexibility to explore different roles and expand your skillset.
• Flexible work hours rather than a strict 9-to-5 schedule.
• Recently acquired by private equity, resulting in significant capital investment and growth potential.
• Experiencing rapid expansion with new teams being built.
• Recently signed a lease for additional office space next door to support continued growth.

Contact
Carlie Goodwin
Quote job ref
JN-072025-6780333