Sr. Quality Engineer - Medical Device

Mission-driven work in a supportive, growth-focused culture

Competitive pay, full benefits, 401(k) match, PTO, and bonus

About Our Client

My client is a fast-growing global manufacturer specializing in advanced engineering, precision manufacturing, and product development for the medical device industry. Known for its innovation and focus on micro-scale technologies, the company supports a wide range of complex medical applications. With a collaborative, improvement-driven culture and ongoing investment in new capabilities, it offers engineers the opportunity to work on cutting-edge technologies in a dynamic, mission-driven environment. This will be at their Hudson, NH facility.

Job Description

Lead and support cross-functional teams throughout the Product Development Process to ensure quality objectives are met

Ensure compliance with 21 CFR 820, ISO 13485, and internal quality systems

Drive and participate in continuous improvement and process validation efforts using tools like DOE, FMEA, Quality Plans, and Gage R&R

Review and approve quality documentation including protocols, validations, investigations, and procedures

Conduct investigations and gather data to support resolution of quality events

Serve as subject matter expert during FDA and regulatory inspections

Develop and maintain process and quality procedures in line with regulatory standards

Implement and monitor continuous improvement metrics to enhance business performance

Act as a liaison for customers on quality-related issues and feedback

Represent Quality function in project team meetings and cross-functional initiatives

Mentor and train engineers and technicians on quality tools, regulatory standards, and best practice

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

7+ years in a Quality Engineering role, ideally in medical device manufacturing or start-up environments

Experience in a hands-on manufacturing setting

Strong technical writing and communication skills

Proven ability to lead and drive projects with attention to detail

Proficiency with statistical analysis tools; Minitab preferred

Bachelor's degree in Engineering or related field (Physics, Optics, Mechanical, Chemical, or Plastics) or equivalent experience

Familiarity with ISO 13485 and 21 CFR 820 quality systems

Knowledge of Lean Manufacturing and Six Sigma methodologies

CQE and/or Six Sigma Green or BlackBelt certification preferred

ASQ certification is a plus

Experience with analytical instrument calibration a plus

Cardiovascular device or related industry experience preferred

Local to Hudson, NH

What's on Offer

Supportive, people-first culture with a focus on work-life balance

Engaging, purpose-driven work developing life-saving medical technologies

Competitive compensation with performance-based bonus opportunities

Comprehensive health benefits and 401(k) with company match

Generous paid time off and parental leave policies

Tuition assistance and professional development support

Inclusive, collaborative environment with transparent leadership

Ongoing employee appreciation events and community involvement initiatives