Senior Digital Quality Systems Analyst

6010-Biosense Webster Inc. Legal Entity; Zug; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Sr Digital QS Business Analyst to translate business requirements into system solutions for MedTech QS applications. You will lead deployments, coordinate validation, and support IT solutions across the Quality Management System landscape.

The role requires a Bachelor’s degree and 4+ years in a regulated industry, with strong communication and project management skills. Opportunity involves cross-functional collaboration and potential domestic/international travel.

Qualifikationen

• 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).
• Additional experience with EtQ, LMSs, PLMs, ERP systems, and Power Apps is a plus.
• Knowledge of Software Development Lifecycle (SDLC) and Computer System Validation (CSV) processes is a plus.

Aufgaben

• Understand business partner needs and translate into IT solutions while balancing tradeoffs.
• Participate on MT-wide multi-functional teams to align IT solutions with Quality Management System requirements.
• Lead deployments for new in-scope systems and platform implementations and upgrades.
• Lead improvements and maintenance of existing in-scope systems (user access, master data, interfaces, automation, validation).
• Coordinate surveillance of user accounts and data extraction for compliance and sustainability.
• Develop and execute test scripts to support compliance of in-scope systems.
• Lead or support projects to support acquisitions, divestitures, network changes, and org changes.
• Develop and maintain global procedures for PLM, Document Management, CAPA, and NC.

Kenntnisse

Coaching

Communication

Compliance Management

Continuous Improvement

Problem Solving

Process Optimization

Quality Control (QC)

Quality Management Systems (QMS)

Regulatory Compliance

SOP

Technologically Savvy

Ausbildung

Bachelor's degree in Computer Science/Engineering/Life Sciences

Tools

EtQ

Learning Management Systems (LMS)

Product Lifecycle Management (PLM)

ERP systems

Power Apps

Jobbeschreibung

Johnson & Johnson is seeking a Sr Digital QS Business Analyst to translate business requirements into system solutions for MedTech QS applications. You will lead deployments, coordinate validation, and support IT solutions across the Quality Management System landscape.

The role requires a Bachelor’s degree and 4+ years in a regulated industry, with strong communication and project management skills. Opportunity involves cross-functional collaboration and potential domestic/international travel.