Quality Systems Tech Lead – Regulated MedTech

Biopharma Careers; Raynham (MA); On-site; USD 102,000 - 204,000; Full time

Job summary

Johnson & Johnson in Raynham, MA is recruiting a Technology Manager, Quality Systems within the DePuy Synthes unit. You will lead business analysis for Quality platforms, bridge Quality, Regulatory, and Manufacturing with technology teams, and oversee a team of individual contributors.

The role focuses on requirements elicitation, process mapping, and validation-ready documentation for systems like CAPA, complaint handling, document management, and audit systems.

Qualifications

• Bachelor-level degree in a relevant field required.
• Masters preferred for advanced roles.
• 8+ years in business/solutions analysis for regulated apps.

Responsibilities

• Lead requirements elicitation, design, and acceptance testing for quality systems.
• Manage teams and performance, with talent development.
• Ensure validation, 21 CFR Part 11, ALCOA+ compliance across platforms.
• Oversee integrations between quality systems and ERP/PLM/manufacturing.

Skills

Analytical reasoning

Consulting

Cost management

Developing others

Leadership

Product development

Project management

Regulatory compliance

Quality systems

SQL/BI basics

Education

Bachelor's degree in Information Systems/Computer Science/Industrial Engineering/Life Sciences/Quality/Business

Master's degree preferred

Tools

Veeva Vault QMS

TrackWise

ETQ

Sparta

SAP integrations

Power BI/Tableau

Job description

Johnson & Johnson in Raynham, MA is recruiting a Technology Manager, Quality Systems within the DePuy Synthes unit. You will lead business analysis for Quality platforms, bridge Quality, Regulatory, and Manufacturing with technology teams, and oversee a team of individual contributors.

The role focuses on requirements elicitation, process mapping, and validation-ready documentation for systems like CAPA, complaint handling, document management, and audit systems.