Staff Quality Engineer – Product Quality

Johnson & Johnson

Staff Quality Engineer at Johnson & Johnson providing quality leadership in medical device software development. Collaborating with teams to enhance processes and ensure compliance with industry standards.

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

About the role

Key responsibilities & impact

Support 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.
Communicate business related issues or opportunities to next management level.
Follow all Company guidelines related to Health, Safety and Environmental practices as applicable.
Ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Requirements

What you’ll need

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.
Enhance processes to better reflect state of the art practices and drive continuous improvement.
Partner with R&D to refine requirements and 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.
Provide guidance to project teams, suppliers, and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations.

Benefits

Comp & perks

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)).
This position is eligible to participate in the Company’s long-term incentive program.
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Software as a Medical Device (SaMD)Test Strategy DefinitionDefect AnalysisVerification Activities DocumentationCode ReviewNon-conformance ManagementRoot Cause InvestigationQuality SystemsContinuous Improvement ProcessesProject Management

Soft Skills

LeadershipCommunicationGuidanceCollaborationMentoring