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# Senior Design Quality Engineer - Medical Device - Medford, NJ

- **Company:** Page Michael International Inc
- **Location:** Medford, NJ, United States
- **Experience:** Expert
- **Salary:** $143,000.0
- **Contract:** Permanent contract
- **Skills:** 21 CFR Part 820 Quality System Regulation, Mdsap
- **Published:** October 1, 2026
- **Apply:** https://www.michaelpage.com/job-detail/senior-design-quality-engineer-medical-device-medford-nj/ref/jn-062026-7036013

## About the Role

* Bachelor's degree in Electrical Engineering; advanced degree preferred.
 * 10+ years of experience within medical devices or another highly regulated industry.
 * Strong experience in Design Controls and Product Development support.
 * Expertise with Risk Management methodologies, including authoring and facilitating risk assessments.
 * Thorough understanding of ISO 13485, FDA 21 CFR Part 820, MDSAP, MDR, and related regulations.
 * Experience supporting Design History Files, validation activities, and quality system compliance.
 * Ability to work independently while effectively collaborating across cross-functional teams.
 * Excellent technical writing, communication, project management, and problem-solving skills.
 * Background in medical instrumentation preferred.
 * Experience within medical devices, defense, military, or similarly regulated industries highly valued.

## Description

We are seeking an experienced Senior Design Quality Engineer to serve as the quality lead for new product development and sustaining engineering initiatives within a highly regulated medical device environment. This role will drive design controls, risk management, Design History File compliance, and cross-functional quality activities from concept through commercialization.

 * Lead quality strategy for innovative Class III medical technologies
 * Own design controls and risk management in a growing organisation, * Act as the Design Controls subject matter expert, ensuring compliance throughout all phases of product development.
 * Partner closely with Product Development teams to drive quality activities for new product introductions and design changes.
 * Lead risk management activities, including risk assessments, risk management plans, and risk management reports.
 * Own and maintain risk documentation supporting product and process development activities.
 * Manage Design History File reviews and verification's throughout the design life cycle.
 * Review and approve engineering change documentation while assessing associated product risks.
 * Support the development, revision, and continuous improvement of quality system procedures and documentation.
 * Review validation protocols and reports to ensure compliance with regulatory and GMP requirements.
 * Conduct internal audits and support Quality Management System effectiveness.
 * Lead investigations related to nonconformances, customer complaints, and corrective actions.
 * Drive timely resolution of quality issues through root cause analysis and corrective action implementation.
 * Provide quality system training and mentorship across the organization.
 * Support compliance with ISO 13485, FDA regulations, MDSAP, MDR, and other global quality standards.
 * Develop technical procedures, failure analysis documentation, and quality engineering reports.