Quality Engineer- Medical Device- Hudson NH

As a Quality Engineer, you will drive continuous improvement of products and processes within a culture that prioritizes doing the right thing. You'll provide guidance and oversight to ensure adherence to procedures and standards, maintaining the safety, efficacy, and regulatory compliance of medical devices.

Client Details

This company has over over 30 years of experience designing and producing surgical equipment-most notably intraoperative Doppler systems and suction‑irrigation tools for use in vascular, urological, neurosurgical, reconstructive, robotic, and general surgery. Their single‑use sterile Doppler probes and robotic suction/irrigation systems are engineered to ensure real‑time vessel detection, cost‑effective reliability, and surgeon autonomy in critical‑care and operating‑room environments.

Description

• Dive into projects with moderate to high complexity-leading compliance reviews, interpreting quality and regulatory demands, and ensuring we always align with the latest guidelines.

• Collaborate on quality-driving initiatives, author and update operating procedures and testing protocols, and craft comprehensive reports that sharpen our processes.

• Conduct deep-dive impact assessments and root-cause analyses-then spearhead corrective/preventive actions that elevate product safety, efficacy, and compliance.

• Use statistical trend analysis (e.g., yield, CAPA, complaints, scrap) to uncover opportunities and fuel continuous improvement efforts across the site.

• Lead risk assessments and FMEAs for new product launches; maintain Design History and Risk Management Files, ensuring robust oversight of product quality and business risk.

Profile

🔧 Technical & Standards Savvy
- Solid familiarity with medical-device quality and risk-management standards (ISO 13485, ISO 14971, ISO 11135, ISO 60601, etc.), ensuring best-in-class regulatory compliance.

🤝 Self-Starter & Team Player
- Equally effective working independently or collaborating in teams; highly adaptable and driven by results.

🗣️ Clear Communicator
- Exceptional verbal and written communication, capable of translating complex technical requirements into actionable plans.

🔍 Detail-Oriented & Proactive
- Meticulous attention to detail combined with a forward-thinking mindset-anticipating challenges before they arise.

Job Offer

Dynamic, Growth-Oriented Environment

In this role, you'll engage in cross-functional collaboration, taking on diverse responsibilities and contributing to various projects. The company's size offers flexibility, allowing you to explore different areas and expand your skill set.

Work-Life Balance and Flexibility

The organization supports a flexible work schedule, enabling you to adjust your hours to fit personal commitments. This approach fosters a healthy work-life balance, accommodating individual needs.

Investment and Expansion

Recently acquired by a private equity firm, the company is undergoing significant investment to enhance its operations and capabilities. This influx of capital is driving substantial growth and development.

Team Development and Opportunities

The company is actively building and expanding its teams, creating numerous opportunities for professional growth and advancement. This dynamic environment encourages innovation and the development of new skills.

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.