Senior Digital Quality Systems Analyst — Hybrid/Remote

6010-Biosense Webster Inc. Legal Entity; Cincinnati (OH); Hybrid; USD 94,000 - 152,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Paid time off

Job summary

Johnson & Johnson is seeking a Sr Digital QS Business Analyst to translate business needs into IT solutions for MedTech QS systems including EtQ, PLM, and ComplianceWire. The role involves leading deployments, maintaining systems, and ensuring compliance across Quality Management processes.

The successful candidate will have a Bachelor’s degree and at least 4 years in quality/regulatory environments, strong collaboration skills, and experience with SDLC/CSV, NC, CAPA, and change control.

Qualifications

• Bachelor’s degree or equivalent required; CS/Engineering/Life Sciences preferred.
• Minimum 4 years of quality, manufacturing, and/or R&D experience in a regulated industry.
• Strong communication, teamwork, and problem-solving skills.
• Experience with NC, CAPA, and change control.
• Knowledge of SDLC and CSV is a plus.

Responsibilities

• Understand business partner needs and translate into IT solutions while balancing tradeoffs.
• Lead deployments for new in-scope systems and platform upgrades.
• Maintain user access management, master data, interfaces, and validation.
• Develop test scripts to support compliance of in-scope systems.
• Support projects across acquisitions, divestitures, and network/organizational changes.
• Create and maintain global procedures for PLM, Document Management, CAPA and NC.
• Manage budgets and communicate issues to management.

Skills

Coaching

Communication

Compliance Management

Continuous Improvement

Controls Compliance

Digital Assurance

Econometric Models

Issue Escalation

Performance Measurement

Problem Solving

Process Optimization

Education

Bachelor’s degree or equivalent

Tools

EtQ

LMS

PLM

ERP

Power Apps

Job description

Johnson & Johnson is seeking a Sr Digital QS Business Analyst to translate business needs into IT solutions for MedTech QS systems including EtQ, PLM, and ComplianceWire. The role involves leading deployments, maintaining systems, and ensuring compliance across Quality Management processes.

The successful candidate will have a Bachelor’s degree and at least 4 years in quality/regulatory environments, strong collaboration skills, and experience with SDLC/CSV, NC, CAPA, and change control.