Staff Quality Engineer Product Quality

Johnson & Johnson Innovative Medicine•Boston, MA

1d•$109,000 - $174,800•Onsite

About The Position

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.

Requirements

Medical Device Software development processes and quality systems
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.
Company policies and procedures, as well as medical device regulations.
Patient’s ePHI and PII data protection and security requirements.
All applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures for Health Care Compliance Program and Code of Conduct.
All Company guidelines related to Health, Safety and Environmental practices as applicable.
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.
Personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Nice To Haves

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

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 patient’s 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.
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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year