Quality Engineer II, Post Market Surveillance

Johnson & Johnson Innovative Medicine•Danvers, MA

2d•Hybrid

About The Position

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.

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.

Nice To Haves

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

Responsibilities

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.

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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))