Quality Engineer II, Post Market Surveillance at Johnson &… · Danvers

Quality Engineer II, Post Market Surveillance Location: Danvers, Massachusetts, United States of America 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for a Quality Engineer II, Post Market Surveillance to be based in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Purpose: A hands-on Quality Engineer II responsible for executing and owning day-to-day Post Market Surveillance (PMS) activities with particular emphasis on responding to PMS data requests, assessing data quality and safety signals, and building/maintaining tools and pipelines to accelerate analysis. This role closes the PMS → Risk Management feedback loop by combining technical quality engineering, data analytics, signal detection, and risk assessment to identify, escalate, and mitigate product-related safety risks in support of regulatory commitments and patient safety. You will be responsible for: Serve as primary technical lead for PMS data requests: receive, scope, prioritize, extract, and deliver curated datasets and analyses to internal stakeholders and regulatory requests. Assess incoming complaint/adverse event data for completeness and quality; apply cleaning, normalization, and coding (e.g., MedDRA-like vocabularies) to prepare data for analysis. Detect, validate, and document safety signals using trend analysis, statistical techniques, and NLP-assisted extraction; recommend and document appropriate follow-up actions. Lead investigations for elevated trends and adverse events; prepare investigation summaries and risk assessments, and recommend CAPAs, labeling changes, or other mitigations as appropriate. Design, implement, and maintain automated extraction and analytics pipelines (ETL, entity extraction, bracketed-capture parsing, mapping to controlled vocabularies) to improve speed, reproducibility, and traceability of PMS analyses. Build and maintain reporting tools and visualizations (dashboards, scheduled reports) to make PMS metrics and signal status accessible to Clinical, Regulatory, Engineering, and Product teams. Maintain inspection-ready PMS records; support audits, inspections, and regulatory information requests with timely, traceable data and documentation. Mentor and review the work of quality analysts and investigators; ensure consistent application of risk standards, coding, and documentation practices. Drive closure and effectiveness verification of CAPAs and risk mitigations arising from PMS activities. Ensure ongoing compliance with QSR, MDR/MPR/MDR-equivalent vigilance requirements, ISO 13485, and country-specific regulatory obligations. Qualifications/Requirements: Minimum BS degree with 3+ years’ professional experience in the medical device quality, post market surveillance, or data analytics. Experience with fulfilling requests from internal and external audits is preferred. Practical experience building or maintaining automated ETL pipelines and reporting dashboards. Ability to travel 10% domestically and internationally. Project management knowledge and understanding. Strong knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 806, ISO 13485 & 14971, EU MDR. Demonstrated ability to create accurate and informative post market surveillance documentation consistent with applicable quality standards. Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability. Must have excellent written and verbal communication skills and have a strong working knowledge of the development, application, and measurement of quality performance metrics. Must be able to work U.S. Eastern Time (EST) hours. Preference toward hybrid in-office work in Danvers, MA; remote option available. 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 & 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. Required Skills: Preferred Skills: Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy The anticipated base pay range for this position is : $79,000.00 - $127,650.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits