Senior Quality Engineer, Post Market Surveillance

Johnson & Johnson Innovative Medicine•Danvers, MA

2d•Hybrid

About The Position

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.

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 datasets (excel).
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

Coaching
Consistency
Controls Compliance
Critical Thinking
Data Savvy
Engineering
Financial Competence
Good Automated Manufacturing Practice (GAMP)
ISO 9001
Lean Supply Chain Management
Leverages Information
Process Improvements
Quality Control Testing
Quality Standards
Quality Systems Documentation
Quality Validation
Science, Technology, Engineering, and Math (STEM) Application
Technologically Savvy

Responsibilities

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (may vary by state)
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