MedTech Quality Systems Tech Leader

Brighter Signals; Raynham (MA); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Travel up to 20%

Health benefits

401(k)

Job summary

Johnson & Johnson is recruiting for a Technology Mgr, Quality Systems, Analyst, located in Raynham, MA or other sites. Leads quality systems portfolio, aligning with Quality and Regulatory strategy, and oversees backlog, analytics, and audits within a regulated MedTech environment.

Responsibilities include ensuring validation, data integrity, and automation opportunities while collaborating with ERP, PLM, and manufacturing systems. Travel up to 20% is possible.

Qualifications

• 8 years of progressive experience delivering enterprise quality systems in a regulated environment.
• Minimum 2 years of experience leading teams and delivering results through others.
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity (ALCOA+).
• Proven experience owning a product roadmap and backlog for a regulated platform portfolio.
• Experience integrating quality systems with ERP (SAP) and manufacturing systems.
• Experience with quality metrics, analytics, and executive reporting.

Responsibilities

• Develops tactical and operational plans to achieve quality systems goals.
• Owns and executes the product roadmap for enterprise quality systems.
• Prioritizes backlog for quality platforms balancing stakeholder needs.
• Leads product functional design for quality system users and processes.
• Directs configuration and support of validated quality platforms (complaint handling, CAPA, document control).
• Oversees analytics and reporting across quality data with dashboards and trends.

Skills

Quality systems

Regulated environments

Leadership

GxP & 21 CFR Part 11

ERP SAP integration

Data analytics

Stakeholder management

Education

Bachelor's degree in a related field

Master's degree preferred

Tools

Veeva Vault QMS

TrackWise

ETQ

Sparta

SAP

Power BI

Job description

Johnson & Johnson is recruiting for a Technology Mgr, Quality Systems, Analyst, located in Raynham, MA or other sites. Leads quality systems portfolio, aligning with Quality and Regulatory strategy, and oversees backlog, analytics, and audits within a regulated MedTech environment.

Responsibilities include ensuring validation, data integrity, and automation opportunities while collaborating with ERP, PLM, and manufacturing systems. Travel up to 20% is possible.