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# Senior Design Quality Engineer

- **Company:** Page Michael International Inc
- **Location:** Philadelphia, PA, United States
- **Experience:** Expert
- **Salary:** $130,000.0
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Document Management Systems, Technical Data Management Systems, Mdsap
- **Published:** June 11, 2026
- **Apply:** https://www.michaelpage.com/job-detail/senior-design-quality-engineer/ref/jn-062026-7037174

## About the Role

* Bachelor's degree in Engineering (Electrical Engineering preferred)
 * 5-10 years of experience in the medical device industry or regulated environment
 * Strong experience in design controls, risk management, and quality or product development engineering
 * Deep knowledge of global quality and regulatory standards (ISO 13485, FDA 21 CFR Part 820, MDSAP, MDR)
 * Experience with medical instrumentation or complex technical products
 * Strong technical writing and documentation skills
 * Proven ability to work independently with minimal supervision
 * Excellent analytical, problem-solving, and root cause investigation capabilities
 * Strong communication and organizational skills with ability to influence cross-functional teams
 * Proficiency with MS Office tools (Word, Excel) and quality documentation systems
 * Experience in regulated industries such as medical devices, defense, or related highly controlled environments preferred

## Description

This role serves as the quality lead within product development, owning design controls, risk management, and regulatory compliance throughout the product lifecycle. You will work cross-functionally to ensure all products meet global quality standards while driving documentation, validation, and continuous improvement activities.

 * Lead design quality and risk activities across product development.
 * Ensure compliant, high-quality product delivery across teams., * Serve as the Design Controls Subject Matter Expert, ensuring proper execution of all design control phases
 * Act as the quality lead on product development teams, ensuring compliance with internal procedures and global regulatory requirements
 * Own and maintain Design History Files (DHF), ensuring completeness and accuracy throughout development phases
 * Lead risk management activities, including authoring plans and reports and facilitating cross-functional risk assessments
 * Ensure all applicable technical standards and design requirements are incorporated into new and modified products
 * Review and approve Engineering Change Orders (ECOs) from external manufacturers and assess associated risk documentation
 * Support development, review, and maintenance of quality procedures, documentation, and technical data forms
 * Ensure adherence to Quality Management System (QMS) processes and documentation requirements
 * Review validation protocols and reports to ensure GMP and regulatory compliance
 * Lead investigations into non-conformances, customer complaints, and CAPAs, ensuring timely resolution
 * Support internal audit activities and ongoing QMS maintenance and improvement efforts
 * Provide training and guidance on quality systems, design controls, and engineering best practices
 * Maintain knowledge of global standards and regulations, including ISO 13485, FDA 21 CFR Part 820/812, MDR, and MDSAP
 * Collaborate cross-functionally with engineering, manufacturing, regulatory, and external partners


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