Senior Quality Engineer- Medical Device- Mount Laurel, NJ

The Senior Quality Engineer will be responsible for supporting new product development in a regulated environment, with responsibility for design controls, risk management, quality systems, and regulatory compliance. Partners with engineering teams to ensure products are developed, validated, and commercialized in accordance with FDA, ISO, and global quality standards in Mount Laurel, NJ.

Client Details

Our client is an established and growing healthcare technology company focused on advancing innovative therapies that improve outcomes for patients with complex chronic conditions. The organization combines clinical expertise, scientific innovation, and a patient-centered approach to develop and commercialize specialized medical technologies. With a growing market presence and ongoing investment in research, product development, and commercialization efforts, the company offers a dynamic environment for professionals seeking to make a meaningful impact in healthcare.

Description

• Serve as the quality representative on cross-functional product development initiatives, ensuring compliance with established quality system requirements throughout the product lifecycle.
• Partner with engineering teams to support design and development activities, including design reviews, documentation oversight, and phase-gate deliverables.
• Lead risk management efforts for new and existing products, including assessments, mitigation planning, documentation, and ongoing risk evaluations.
• Review and approve design changes, technical documentation, and engineering modifications to ensure alignment with quality and regulatory expectations.
• Support verification, validation, and product realization activities by assessing protocols, reports, and associated documentation for accuracy and completeness.
• Investigate quality issues, nonconformances, and customer-related concerns, driving corrective and preventive actions through effective root-cause analysis.
• Contribute to the development, maintenance, and continuous improvement of quality management system processes, procedures, and training materials.
• Provide technical leadership on quality and regulatory requirements while collaborating with internal stakeholders, suppliers, and external partners to support successful product commercialization.

Profile

• Bachelor's degree in Engineering or a related technical discipline; Master's degree preferred.
• Demonstrated experience supporting product development and risk management with class III medical devices.
• Strong understanding of quality systems, product development processes, and lifecycle management principles.
• Experience leading or supporting risk management, design reviews, verification, and validation activities.
• Proven ability to interpret and apply regulatory requirements, industry standards, and quality system expectations.
• Strong analytical and problem-solving capabilities with experience investigating complex technical and quality-related issues.
• Effective communicator who thrives in cross-functional environments and can influence stakeholders across engineering, quality, operations, and regulatory teams.
• Highly organized, self-motivated professional with excellent attention to detail and the ability to manage multiple priorities with minimal supervision.

Job Offer

• Opportunity to play a key role in the development and commercialization of innovative healthcare technologies that have a meaningful impact on patient outcomes.
• High-visibility position with significant influence across product development, engineering, quality, and regulatory functions reporting directly into the VP of Quality
• Excellent benefits including 10% annual bonus, free healthcare (family plan included), and 6% 401k match.
• Hybrid opportunity with 75% projected remote flexibility.

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.