Staff Quality Engineer Product Quality

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.

Job Function:

R&D Product Development

Job Sub Function:

R&D Software/Systems Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Boston Massachusetts United States of America Gières Isere France Raynham Massachusetts United States of America

Job Description:

The Staff Quality Engineer Product Software Development will provide quality leadership on new product project teams responsible for the development of medical device software systems. The Staff Quality Engineer will 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.

DUTIES & RESPONSIBILITIES

• 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. 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.

• Provide guidance to project teams suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.

• Ensure that patients ePHI and PII data is protected and security requirements are met.

• Know understand incorporate and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures for Health Care Compliance Program and Code of Conduct.

• Additionally:

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

• For those who supervise or manage a staff responsible for ensuring 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

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

EXPERIENCE AND EDUCATION*

• A bachelors degree or university degree is required. An advanced degree is preferred.
• Degrees in Engineering Computer Science Information Systems Biomedical/Bio-engineering Degree preferred.
• A minimum of 6 years of regulated industry experience in a quality new product development or manufacturing engineering capacity is required.
• Experience with the development of Software as a Medical Device (SaMD) or System Development Life Cycle (SDLC) for medical device software is strongly preferred.
• Prior experience leading coaching or mentoring other engineers or project core team members is required.
• Demonstrated ability to lead synchronize and motivate personnel both within and outside immediate control to meet goals and objectives.
• The ability to meet departmental goals/objectives is required.
• Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required.
• Additional experience in functional areas outside of Quality (e.g. IT Engineering Software Development).
• Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Ability to work in a team and demonstrate good interpersonal organizational and verbal/written communications skills.
• Extensive use of the personal computer and associated work tools (Word Excel Power Point) is required.
• Medical device industry experience.
• ASQ Certification as a Software Quality Engineer or equivalent is preferred.

Required Skills:

Preferred Skills:

Agility Jumps Analytical Reasoning Coaching Collaboration Critical Thinking Model-Based Systems Engineering (MBSE) Product Design Report Writing Requirements Analysis Research and Development SAP Product Lifecycle Management Scripting Languages Software Architectures Software Development Management Software Engineering Practices Software Quality Assurance (SQA) Systems Development Lifecycle (SDLC) Technologically Savvy

The anticipated base pay range for this position is :

$109000.00 - $174800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

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

For additional general information on Company benefits please go to: - Experience:

Staff IC