Staff Quality Engineer – Product Quality

Johnson & Johnson

Staff Quality Engineer providing quality leadership in medical device software development. Focused on requirements gathering, risk assessments, and compliance with industry standards.

Posted 7/10/2026full-timeRaynham • Massachusetts • 🇺🇸 United StatesLead💰 $109,000 - $174,800 per yearWebsite

About the role

Key responsibilities & impact

Provide quality leadership on new product project teams responsible for the development of medical device software systems.
Be the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.
Partner with R&D to refine requirements, and to ensure compliant architecture/design documents.
Own the development of risk documents and facilitate software risk assessment sessions.

Requirements

What you’ll need

Responsible for supporting the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
Provide leadership, guidance and expertise on the software development process, procedures and practices.
Enhance processes to better reflect state of the art practices and drive continuous improvement.
Partner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive.
Facilitate the documentation and tracking of verification activities, including code review findings.
Review test case execution results and manage defects.
Facilitate software risk assessment sessions and own the development of risk documents.
Support regulatory filings and registrations.
Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.
Provide technical support for audits of software suppliers and software consultants.
Conduct training on Medical Device Software development processes and quality systems.
Train and mentor new engineers and lower-level quality engineers.
Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366, ISO 27001, and HIPAA.

Benefits

Comp & perks

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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Requirements GatheringTest Strategy DefinitionDefect AnalysisVerification Activity DocumentationCode ReviewContinuous Improvement ProcessesSoftware Development ProceduresRisk Document DevelopmentAudit SupportRoot Cause Investigation

Soft Skills

LeadershipGuidanceCollaborationCommunicationMentoring

Certifications

IEC 62304FDA GuidanceFDA Part 11ISO 13485EU MDRISO 14971IEC 62366ISO 27001HIPAA