Quality Engineer II, Post Market Surveillance

• Job title Quality Engineer II, Post Market Surveillance
• Function Supply Chain Engineering
• Sub function Quality Engineering
• Category Experienced Engineer, Quality Engineering (ST5)
• Location Danvers / United States of America
• Date posted Apr 30 2026
• Requisition number R-072858
• Work pattern Fully Remote

This job posting is anticipated to close on May 07 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.

Description

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.

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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.

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The anticipated base pay range for this position is :

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