Senior Quality Engineer, Post Market Surveillance

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 Senior Quality Engineer, Post Market Surveillance to be located 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: This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes. Hands on Senior Quality Engineer responsible for executing and owning PMS-related quality activities with clear accountability for the PMS → Risk Management feedback loop. This role combines technical quality engineering, signal detection, and risk assessment to ensure timely identification, escalation, and mitigation of product related safety risks in support of regulatory commitments and patient safety.

 

You will be responsible for:

• Own day‑to‑day quality execution for Post‑Market Surveillance activities and ensure PMS outputs feed directly into Risk Management actions (assessments, CAPAs, risk‑acceptance decisions).
• Detect and validate safety signals from complaint/adverse event data (trend analysis, statistical review, and NLP‑assisted extraction); document findings and recommended actions.
•  Lead investigations for elevated trends and adverse events, perform trend analysis, and evaluate recommended actions.
• Prepare and present PMS data, investigation summaries, and risk assessments to management and cross‑functional stakeholders; escalate when thresholds are met.
• Maintain inspection‑ready PMS records and support regulatory information requests, audits, and inspections.
• Implement and maintain automated extraction/analytics pipelines (e.g., bracketed capture parsing, entity extraction, mapping to controlled vocabularies) to improve data quality and speed of analysis.
• Mentor and review work of quality analysts and investigators performing risk assessments; ensure consistent application of risk standards and coding.
• Contribute to creation of annual PMS reports and other regulatory deliverables as required.
• Ensure compliance with QSR, MDR/MDV/MPR, ISO 13485, and country‑specific vigilance/regulatory requirements.
• Act as a quality liaison across Clinical, Regulatory, Engineering, Product and Data teams to investigate relationships among device factors, procedures, medications, and adverse events.
• Drive closure and effectiveness verification of CAPAs and risk mitigations arising from PMS activities.

 

Qualifications/Requirements:

• Minimum BS degree with 5+ years’ professional experience in the medical device quality, post market surveillance, or risk management.
• Experience with fulfilling requests from internal and external audits is preferred.
• Demonstrated expertise in handling of large da