Software Quality Engineering Lead

Job Duties: Manage Direct Reports and oversees their medical device software projects to ensure compliance to local procedures and regulatory requirements. Review 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 company procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ 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.

Requirements: Employer will accept a Bachelor’s degree in Computer Science, Engineering or related field and 8 years of experience in the job offered or in a Software Quality Engineering Lead-related occupation.

*Certified Software Quality Engineer (CSQE) certification required.

*Project Management Professional (PMP) certification required.

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.

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.