Senior Design Quality Engineer

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Raynham, Massachusetts, United States of America

Job Description:

Employer:          DePuy Synthes Products, Inc.

Job Title:            Senior Design Quality Engineer

Job Code:           A011.8070

Job Location:     Raynham, MA

Job Type:            Full-Time

Rate of Pay:       $104,000 - $114,400/year

Job Duties: Review all project program deliverables (e.g.

plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).

Provide direction and leadership for verification and validation of digital health technologies.

Guide in establishing product and software requirements, specifications, detailed design, verification and validation protocols and planning documentation.

Collaborate with project and program teams to ensure results comply with DePuy Synthes procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g.

21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance.

Provide Quality representation during problem resolution.

Participate in technical design reviews and project phase reviews.

Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.

Identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc.

Support internal audits and external audits by regulatory agencies, as required.

Requirements: Employer will accept a Bachelor's degree in Mechanical Engineering, Mechatronics Engineering, Electrical Engineering, Biomedical Engineering or related field and 3 years of experience in the job offered or in a Senior Design Quality Engineer-related occupation.

This job posting is anticipated to close on 7/7/2025.

Johnson & Johnson is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are prote...