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Johnson & Johnson

Quality Systems (QS) Digital Strategy & Deployment Lead

West Chester, PA

Johnson & Johnson Medical Device Companies is recruiting for a Quality Systems (QS) Digital Strategy & Deployment Lead. This position can be based in Raritan, NJ or any other major J&J Medical Device Companies facilities in the US (Raynham, MA; Cincinnati, OH; Palm Beach Gardens, FL; West Chester, PA; Milpitas, CA; Santa Clara, CA).

At Johnson & Johnson Medical Device (MD) Companies, we use technology and the power of collaboration to discover new ways to prevent and overcome the world's the most significant healthcare challenges. Medical Device Quality Systems organization leverages modern technology solutions, data, real-world insights, and creative minds to support development of life-changing products. We're disrupting traditional way of working by infusing our existing best practice with transformative ideas to help MD businesses thrive throughout every stage product lifecycle and deliver the highest quality experiences for our patients, consumers, and customers in an increasingly connected and personalized world.

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MD QS Digital Strategy & Deployment Lead primarily supports the Medical Device Quality Systems organization's effort to drive MD wide Digital Product Quality Program and independently drive QS specific automation, technology/solution deployment, validation and PLM configuration management projects. The position engages with medical device product teams across MD operating companies as well as IT and other functional organizations to identify transformative opportunities, lead priority assessment, facilitate strategy planning/implementation planning and lead execution through collaboration with the stakeholders and MD QS leaders, and manage deployment up to base business transition. This position will lead planning and execution conversations with mid to senior level partners and management representatives to develop new process, technology and change management solutions while providing the guidance needed to ensure compliance with the company's Quality System policies, procedures and applicable external requirements and standards.

Key Responsibilities:
  • Leader within MD Digital Product Quality Program team, the role brings up transformative improvement & bold new opportunities through continuous engagement with stakeholders
  • Leads value-driven prioritization of improvement opportunities, perform landscape/baseline assessment, execute implementation plan through FPX + Agile or similar methodology and prescribe an approach and drive solutions.
  • Execute implementation by working with MD Medical Device Software platform teams, Quality Systems & Post Market Quality organization, and internal & external technology solution vendors as well as benchmarking external best practices.
  • Understand business partners and stakeholders (primarily Medical Device Software teams and Quality Systems & Post Market Quality organization) needs and translate into solutions while balancing tradeoffs and business impact.
  • Participate in J&J Enterprise Level effort around Medical Device Software standards and technology deployment as an MD Lead SME, such as multi-functional teams to integrate IT solutions to optimally meet the requirements of the Quality Management System
  • 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.
  • Develop and maintain standardized procedures, work instructions, knowledge articles needed for implementation of solutions and changes within the scope of work.

Qualifications

Required:
  • A minimum of a Bachelor degree is required; a degree concentration in Computer Science, Engineering, Life Sciences, Data Science or subject area is an asset.
  • Minimum of 6 years of work experience in Medical Device (any combination of ISO 13485, 14971, 62304, 27001 and Annex/Part 11 - or similar regional equivalent i.e. FDA).
  • Strong communication, collaboration and social skills to engage stakeholders, create an environment openly entertain new ideas/solutions, lead discussions to align objectives across stakeholders and gain their buy-in.
  • Capability to build a consensus and leading stakeholders through process, technology solution, or organizational change.
  • Ability to articulate cerebral or ambiguous ideas and observations into clear set of problem statements or solutions.
  • Strong project management skill.
  • Working knowledge of software, system or technology solution development and lifecycle management is required.
  • Flexible with the ability to work independently as well as on teams with excellent time management skills to handle multiple projects and deadlines required.

Preferred:
  • Hands on work experience in Medical Device R&D, Q&C, 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 AWS, Azure, Selenium, Blue Prism, Python, Java, R, etc.
  • Hands on work experience in Medical Device Design Control and Risk Management preferred, including NPD, NPI, LCM, QS and Post Market Quality experience
  • Up to 10% travel, regionally and internationally required.


Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Raritan-1000 US HIghway 202
Other Locations
North America-United States-California-Santa Clara, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-California-Milpitas, North America-United States-Massachusetts-Raynham, North America-United States-Florida-Palm Beach Gardens
Organization
Medical Device Business Services, Inc (6029)
Job Function
Info Technology
Requisition ID
2105970872W

Job ID: Johnson&Johnson-2105970872W-en-us-3
Employment Type: Other

This job is no longer available.

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