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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 protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Please refer the Job description for details