Primary Software Quality Engineer - Ottava
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com . 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.
Requirements
- Employer will accept a Master's degree in Electrical Engineering, Computer Science or related field and 6 months of experience in the job offered or in a Primary Software Quality Engineer - Ottava-related occupation.
Responsibilities
- Support computerized system validation activities for various platforms' Non-Product software in Surgical Robotics product development.
- Identify and implement necessary changes to ensure and maintain the continued suitability and effectiveness of the quality management system (QMS) using quality policy, quality objectives, audit results, and analysis of data.
- Apply a risk-based approach for QMS processes.
- Provide direction and support for verification and validation (V&V) of product software, non-product software, software tools, and components.
- Guide the establishment of documentation for software requirements, specifications, detailed design, V&V protocols, planning, and change control.
- Collaborate with project/program teams to ensure software deliverables and tasks align with applicable company procedures, global standards (ISO 13485, ISO14971, IEC62304), and regulations (21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/Medical Device Regulation (MDR)).
- Review all project/program software deliverables, such as plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, and reports.
- Review and assess development activities including user needs, development/quality plans, requirements, architecture and design, and V&V to ensure alignment with applicable procedures, standards, and regulations.
- Participate in technical design reviews and project phase review.
- As needed, support CAPA and/or internal and external audits.
- Communicate business related issues or opportunities to management.
Benefits
- 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.
- 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
- This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
