Quality Systems Tech Lead – Regulated MedTech

Johnson & Johnson Co.; Raynham (MA); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson’s DePuy Synthes is recruiting for a Technology Manager, Quality Systems, Analyst. The role leads the quality systems portfolio, manages a team, and partners with Quality, Regulatory, and Manufacturing to drive improvements in CAPA, change control, document management, and audit readiness.

Based in Raynham, MA with regional responsibilities. The position emphasizes GxP compliance, 21 CFR Part 11, data integrity, and cross-functional collaboration to enable automation and

Qualifications

• Bachelor’s degree in a relevant field.
• 8 years of progressive experience with enterprise quality systems.
• 2+ years of team leadership experience.
• Experience integrating quality systems with ERP (SAP) and PLM.

Responsibilities

• Develops tactical and operational plans to achieve quality systems goals.
• Owns and executes the product roadmap for quality platforms.
• Maintains backlog for quality platforms balancing stakeholder needs.
• Directs the design process based on quality system user knowledge.
• Manages validation, documentation, and change control for platforms.
• Leads analytics and reporting from quality data for leadership visibility.
• Coordinates audits and regulatory inspections as technology liaison.

Skills

Quality systems

GxP knowledge

21 CFR Part 11

Backlog management

Roadmap ownership

Stakeholder management

Team leadership

ERP SAP integration

Education

BS in CS/IS/Eng

MS in IS/Eng/Business

Job description

Johnson & Johnson’s DePuy Synthes is recruiting for a Technology Manager, Quality Systems, Analyst. The role leads the quality systems portfolio, manages a team, and partners with Quality, Regulatory, and Manufacturing to drive improvements in CAPA, change control, document management, and audit readiness.

Based in Raynham, MA with regional responsibilities. The position emphasizes GxP compliance, 21 CFR Part 11, data integrity, and cross-functional collaboration to enable automation and