Quality Engineer - Medical Device - New Brunswick, NJ

play a pivotal role in improving life-saving vascular medical devices used world

Join a growing, innovation-driven organization with strong quality culture

About Our Client

My client is a global medical device company specializing in vascular technologies that serve patients in more than 90 countries. Their North Brunswick facility manufactures advanced collagen vascular grafts used in critical surgical applications. With a strong reputation for quality, innovation, and patient impact, they continue to expand operations and invest in high-performing technical talent.

Job Description

The key responsibilities of the Quality Engineer Include:

Lead and support root-cause investigations, NCMRs, and CAPA activity to strengthen product quality.

Execute and maintain risk management files in alignment with ISO 13485, ISO 11138-7, and ISO 14971.

Oversee environmental monitoring programs, including bioburden assessments and excursion response.

Provide engineering guidance for calibration programs and quality oversight of related activities.

Develop and execute validations, technical studies, test method validations, protocols, and reports.

Apply SPC, statistical analysis, and Six Sigma tools to evaluate processes and drive continuous improvement.

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.

The Successful Applicant

A Successful Quality Engineer Candidate may:

Holds a bachelor's degree in Microbiology, Biology, Biomedical Engineering, or a related field.

Brings 2-6 years of professional experience in a regulated quality environment, ideally medical devices.

Has working knowledge of relevant standards such as ISO 13485, ISO 11138-7, and ISO 14971.

Demonstrates strong analytical skills with proficiency in MS Word, Excel, PowerPoint, and Outlook.

Communicates clearly, collaborates well cross-functionally, and is comfortable in an FDA-regulated setting.

Excels at problem-solving, data analysis, and driving timely, compliant quality documentation.

What's on Offer

On offer for the Quality Engineer is:

Opportunity to contribute directly to life-improving medical technologies.

A collaborative, mission-driven team focused on quality and operational excellence.

Professional development, hands-on exposure, and advancement potential within a growing company.

Competitive compensation aligned with experience level.

A stable, established company with global footprint and strong product pipeline.

A fast-paced, technically engaging environment where your work has meaningful patient impact.

Contact

Megan Obrien

Quote job ref

JN-