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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:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is currently recruiting a Quality Engineer II - PMS may be based out of Warsaw, IN, Raynham, MA, or West Chester, PA.

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/

Position Overview

The PMS Quality Engineer II supports Post Market Surveillance (PMS) activities for DePuy Synthes within J&J MedTech. This role independently leads risk management, data analysis, and signal assessment activities to ensure product safety and regulatory compliance. The engineer collaborates across functions and communicates effectively to drive investigations and continuous improvement.

Responsibilities

+ Execute PMS processes including signal assessments, trend analysis, product investigations, and reporting (PMS Plans, PMS Reports, PSURs).

+ Lead cross-functional reviews and escalate product performance issues.

+ Prepare and maintain PMS documentation per regulatory requirements.

+ Support CAPA activities and continuous improvement initiatives.

+ Ensure compliance with applicable laws, regulations, and company policies.

+ Engage with internal teams (R&D, Medical Affairs, Regulatory, Marketing, etc.) and external stakeholders including Health Authorities.

+ May participate in customer interviews and field visits.

+ Travel up to 10% may be required.

Qualifications

+ Bachelor’s degree in Engineering, Scientific, or related field (e.g., Data Science, Biostatistics, Public Health).

+ Minimum 2 years’ experience in a regulated industry (Medical Device, Pharma, etc.) or educational equivalent.

+ Strong problem-solving, root cause analysis, and communication skills.

+ Experience in PMS, Design Control, and statistical analysis preferred.

+ Proficiency in Microsoft Office; programming experience a plus.

+ Familiarity with FDA and EU medical device regulations preferred.

+ Lean/Six Sigma training or certification is a plus.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

\#Li-Hybrid

The anticipated base pay range for this position is :

$63,000 - $102,350

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.