Senior Quality Engineer, 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 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 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 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 daytoday quality execution for PostMarket Surveillance activities and ensure PMS outputs feed directly into Risk Management actions (assessments CAPAs riskacceptance decisions).
• Detect and validate safety signals from complaint/adverse event data (trend analysis statistical review and NLPassisted 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 crossfunctional stakeholders; escalate when thresholds are met.
• Maintain inspectionready 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 countryspecific 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 () or contact AskGS to be directed to your accommodation resource.

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Senior IC