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 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.
• 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:

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

 

 

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

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