Note: The job is a remote job and is open to candidates in USA. Johnson & Johnson MedTech develops innovative, personalized healthcare treatments at the intersection of biology and technology. The Sr Digital QS Business Analyst translates business requirements into system solutions for MedTech Quality System applications and leads implementations, upgrades, maintenance, validation, compliance, and continuous improvement activities.
Responsibilities
- Understand business partner needs and facilitate translation into IT solutions while balancing tradeoffs and business impact to resolve system issues
- Participate on MT-wide multi-functional teams to integrate IT solutions to optimally meet the requirements of the Quality Management System and meet customer/patient needs
- Lead deployments for new in-scope systems and capabilities as well as related platform implementations and upgrades
- Lead improvements and maintenance of existing in-scope systems, including but not limited to user access management, master data management, configuration changes, interfaces, process changes, automation, remediation, and validation
- Coordinate surveillance of user accounts and records, as well as data extraction, compilation, and analytics for compliance and sustainability or project support
- Develop and execute test scripts to support compliance of in-scope systems
- Lead or support various projects as assigned by management and in support of our digital roadmap, including projects to support acquisitions & divestitures, network changes, and org changes (small enhancements to large program deployments)
- Develop and maintain global procedures and processes for in-scope systems associated with PLM, Document Management, CAPA and NC for continuous improvement
- Manage spending within approved budgets
- Responsible for communicating business-related issues or opportunities to next management level
- For those who supervise or manage a staff (including contractors), 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
- Perform other duties assigned as needed
Skills
- Minimum of a Bachelor's degree or equivalent is required; a degree concentration in Computer Science, Engineering, Life Sciences, or related subject area is an asset
- A minimum of 4 years of quality, manufacturing, and/or R&D experience within a regulated industry, is required
- Strong communication, teamwork, and problem-solving skills are essential for success in this role
- Proven understanding of project management principles
- Ability to analyze, balance, and prioritize risk in a dynamic environment
- Demonstrated commitment to prioritizing customer and patient needs
- Proven track record implementing Quality System improvements to meet compliance and overall business goals
- Experience with NC, CAPA, and change control
- Demonstrated skill in effectively analyzing relevant information and reaching independent decisions in a timely manner
- Above average digital literacy and command of commonly used business applications (i.e. Microsoft Office, Copilot AI)
- This position may require up to 5% domestic and international travel
- Additional experience with EtQ, Learning Management Systems (LMSs), Product Lifecycle Management (PLMs), ERP systems, and Power Apps is a plus
- Knowledge of Software Development Lifecycle (SDLC) and Computer System Validation (CSV) processes is a plus
Benefits
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of their respective plans.
- Vacation – 120 hours per calendar year, subject to the terms of the applicable policies and date of hire.
- Sick time – 40 hours per calendar year; employees who reside in Colorado receive 48 hours per calendar year; employees who reside in Washington receive 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, or 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.
- Hybrid work model, ideally with 3 days onsite and 2 days remote.
- Remote work options may be considered on a case-by-case basis if approved by the Company.
Company Overview