Quality Engineer II, Post Market Surveillance

Job Summary
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.

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, escalates, and mitigate product‑related safety risks in support of regulatory commitments and patient safety.

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.

Qualifications

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.

Pay and Benefits
Anticipated base pay range: $79,000.00 - $127,650.00.

Benefits Overview

Vacation – 120 hours per calendar year

Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents)

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

Retirement plan (consolidated pension and 401(k) plan) and other benefits available to eligible employees.

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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