Quality Systems Tech Manager (MedTech)

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

Benefits offered by this job

Domestic travel

Job summary

Johnson & Johnson's DePuy Synthes unit seeks a Technology Manager, Quality Systems, BA, to lead the business analysis for quality platforms across the Supply Chain Technology function. The role steers a team of contributors and ensures validation, change control, and data integrity per ALCOA+ standards.

You will bridge Quality, Regulatory, and Manufacturing process owners with tech teams, shaping requirements, designs, and UAT for compliant platforms.

Qualifications

• Minimum 8 years of progressive experience in business analysis, systems analysis, or solution delivery for regulated business applications in a manufacturing or MedTech environment.
• Minimum 2 years of experience leading teams, with demonstrated ability to manage performance, develop talent, and deliver results through others.
• Deep hands-on experience gathering and documenting requirements for enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent).
• Strong working knowledge of GxP, 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements as they apply to requirements and design documentation.
• Proven experience producing functional specifications, user stories, acceptance criteria, process flows, and requirements traceability matrices.
• Experience leading user acceptance testing, defect management, and business readiness for validated system releases.
• Strong process analysis skills, including current/future-state mapping and gap identification across regulated workflows.
• Experience defining integration requirements between quality systems and ERP, PLM, or manufacturing platforms.

Responsibilities

• Develops tactical and operational plans to achieve quality systems business analysis goals, and communicates plans to managers, supervisors, and individual contributors.
• Directs requirements elicitation, analysis, and documentation across quality processes including complaint handling, CAPA, nonconformance, deviations, change control, document management, training, and audit management.
• Leads the product functional design process based on an intimate knowledge of quality system users, regulated processes, and platform capability.
• Prioritizes and maintains the backlog for assigned quality platforms, balancing the requirements of Quality process owners, Regulatory, Manufacturing, and Technology stakeholders.
• Oversees translation of business requirements into user stories, functional specifications, acceptance criteria, and traceability matrices suitable for a validated environment.
• Directs current-state and future-state process analysis, identifying gaps, inefficiencies, and automation opportunities across quality workflows.
• Governs solution design reviews to ensure proposed configurations meet business need, regulatory requirements, and platform architectural standards.
• Leads user acceptance testing strategy and execution, including test script authorship, defect triage, and go/no-go recommendation.
• Ensures requirements and design artifacts satisfy computer system validation, change control, and documentation obligations under GxP, 21 CFR Part 11, and data integrity (ALCOA+).
• Directs impact assessment and requirements definition for integrations between quality systems and ERP (SAP), PLM, manufacturing, and post-market surveillance platforms.
• Partners with Quality leadership to define process and system KPIs, and translates reporting needs into platform requirements.
• Assesses the quality systems implications of technology change — including platform migrations, ERP implementations, and separation/carve-out activity — and defines requirements ahead of cutover.
• Anticipates bottlenecks, provides escalation management, and builds consensus by understanding stakeholder requirements and constraints.
• Leads business readiness, training material development, and change management to support adoption of new and enhanced quality system capabilities.

Skills

Business analysis

GxP knowledge

21 CFR Part 11

Requirements management

SQL

Power BI

Tableau

Agile/Scrum

Regulatory inspections

Education

Bachelor's degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or a related discipline

Master's degree in Information Systems, Engineering, or Business Administration

Tools

Power BI

Tableau

SQL

Job description

Johnson & Johnson's DePuy Synthes unit seeks a Technology Manager, Quality Systems, BA, to lead the business analysis for quality platforms across the Supply Chain Technology function. The role steers a team of contributors and ensures validation, change control, and data integrity per ALCOA+ standards.

You will bridge Quality, Regulatory, and Manufacturing process owners with tech teams, shaping requirements, designs, and UAT for compliant platforms.