Quality Engineer II, Post Market Surveillance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 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.

You will be responsible for:

• 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/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.
• 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 () or contact AskGS to be directed to your accommodation resource.

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