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Johnson & Johnson is looking to solve the problem of driving MedTech wide Digital QMS Program and independently driving QS automation, technology/solution deployment, validation and PLM configuration management projects.

Requirements

• A minimum of 4 years of work experience in MedTech and software business (any combination of ISO 13485, FDA CSA, GAMP5, and Part 11 – or similar regional equivalent i.e. FDA).
• Strong project management skill.
• Solid understanding of software, system or technology solution development and lifecycle management is required.
• Hands on work experience in Q&C experience in Software development using modern tools (i.e. Jira/Xray, Bitbucket, Jenkins, Sonarqube, Polarion, Cognition, etc) preferred.
• Hands on work experience with modern RPA, AI/ML, and other automation technology platforms, solutions, or languages such as Microsoft Power Platform, Power Fx, Python, Java, R, etc.
• Hands on work experience in Digital Asset Management as Software Quality Engineer in terms of Compliance Assessment inclusive of risk assessment of GxP, Security, Privacy, Records Retention, etc..
• Flexible with the ability to work independently as well as on teams with excellent time management skills to balance multiple projects.

Responsibilities

• Provide SME support to MedTech NPS teams in planning and development, validation and change management of GxP software solutions.
• Develop, execute, and oversee validation plans, strategies, and reports for GxP software solutions.
• Support MedTech Digital Asset Management governance process through Compliance Assessment and providing operational assistance and training.
• Leads value-driven prioritization of improvement opportunities, lead continuous improvement projects by working by working with cross functional teams.
• Understand business partners and stakeholders’ needs and translate into GxP solutions while balancing tradeoffs and business impact.
• Participate in J&J Enterprise Level effort around MedTech Software standards and technology deployment as an SME, such as multi-functional teams to integrate IT solutions to optimally meet the requirements of the MedTech Digital QMS.
• Supervise contract resources and mentor GROW resources to achieve milestones on time and develop the less seasoned high potential talent to build continuous talent pipeline.

Other

• A minimum of a Bachelor degree is required; a degree concentration in Computer Science, Engineering, Life Sciences, Data Science or related field is preferred.
• Up to 10% travel, regionally and internationally required.
• Strong communication, collaboration and social skills to engage partners, build an environment openly entertain new ideas/solutions, lead discussions to align objectives across partners and gain their consensus.
• Ability to articulate cerebral or ambiguous ideas and observations into clear set of problem statements or solutions.
• Capability to build a consensus and leading collaborators through process, technology solution, or organizational change.