Sr. Quality Engineer - Medical Device - Hudson, NH

The Quality Engineer - Medical Devices supports product development, manufacturing, and improvement initiatives to ensure compliance with regulations and internal quality systems. This role leads process validation, root cause analysis, and quality tool implementation to deliver safe, effective products.

Client Details

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.

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

Profile

• 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

Job 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

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.