Senior Software Quality Engineer

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

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at & Johnson is recruiting for a Senior Software Quality Engineer located in Santa Clara CA.

Our team advances the MONARCH surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals skills.

The Senior Software Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of cutting-edge technology for medical devices is safe effective and compliant with regulations standards and industry practices. Working closely with multi-functional teams this individual will act as an authority for both product and non-product software quality throughout the development lifecycle. The individual reviews and assesses software activities (e.g. user needs software development plans software requirements software architecture and design product security software verification and validation) to ensure that they comply with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA Complaints software problem resolution and both Internal and External Audits.

Key Responsibilities:

• Review all project / program software deliverables (e.g. plans requirements specifications test protocols test cases test results traceability risk management documents reports).

• Provides direction and leadership for verification and validation of non-product software products software software tools and components.

• Provide expertise in establishing good software requirements specifications detailed design verification and validation protocols and planning documentation. Collaborate with project / program teams to ensure software deliverable comply with RADS procedures global ISO standards (ISO 13485 ISO14971 IEC62304) regulations (e.g. 21 CFR Part 820 21 CFR Part 11 European Medical Device Regulation (MDR) and applicable guidance.

• Provide Quality representation during software problem resolution.

• Participate in technical design reviews and project phase reviews.

• Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.

• Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy quality objectives audit results analysis of data etc.

• Support internal audits and external audits by regulatory agencies as required.

Qualifications

Required:

• Bachelor of Science degree inElectrical Computer Science or any related engineering field.

• 6 years experience with quality assurance with a focus on software testing design control of software development software verification and validation.

• 3 years experience in a quality role within the medical device aerospace/defense or similarly regulated industry.

• Strong verbal and written communication skills; ability to present issues plans and objectives.

• Excellent organizational problem solving and analytical skills

• Working knowledge of IEC 62304 FDAs General Principles of Software validation ISO 13485 ISOCFR 820 IEC 60601-1 and MDR.

• Ability to lead cross-functional teams in problem solving and risk analysis activities.

• Ability to manage priorities and workflow Versatility flexibility and a willingness to work within constantly evolving priorities

Preferred:

• Masters or Advanced Degree

• ASQ certification as a Software Quality Engineer

Other:

• Ability to travel up to 10% domestic and international is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Senior IC