Technology Mgr, Quality Systems, Analyst

Johnson & Johnson Innovative Medicine•Raynham, MA

1d•$102,000 - $204,000•Hybrid

About The Position

The Technology Manager, Quality Systems, Analyst leads the technology capability supporting DePuy Synthes enterprise quality systems within the Supply Chain Technology function, Quality sub-function. This role manages a team of individual contributors and/or supervisors and is accountable for effective performance management, capability building, and career development. The Manager develops tactical and operational plans for the quality systems portfolio, owns and executes the product roadmap across complaint handling, CAPA, nonconformance, document management, training, and audit platforms, and prioritizes and maintains the backlog balancing the requirements of Quality, Regulatory, Manufacturing, and Technology stakeholders. Operating in a regulated MedTech environment, the role ensures all platform changes meet GxP, 21 CFR Part 11, and data integrity requirements while driving analytics, automation, and continuous improvement across the quality technology landscape.

Requirements

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, Industrial Engineering or a related discipline.
8 years of progressive experience delivering and supporting enterprise quality systems or 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 with enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent) across complaint, CAPA, nonconformance, and document control processes.
Strong working knowledge of GxP, 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements.
Proven experience owning a product roadmap and backlog for a regulated platform portfolio.
Experience defining quality metrics, analytics, and executive reporting from quality system data.
Experience integrating quality systems with ERP (SAP), PLM, and manufacturing systems.
Experience managing vendors, system integrators, or managed service partners against defined SLAs.
Strong stakeholder management and communication skills, with proven ability to influence Quality and Regulatory leadership.
English proficiency required.

Nice To Haves

Master's degree in Information Systems, Engineering, or Business Administration.
MedTech or medical device experience; familiarity with ISO 13485, EU MDR, and FDA QSR/QMSR requirements.
Experience leading quality systems migration, consolidation, or stand-up within a divestiture, carve-out, or standalone entity.
Experience applying Generative AI / LLM-enabled tooling to complaint triage, document review, or quality record analysis, with appropriate validation controls.
Familiarity with Agile/Scrum delivery and backlog-driven product management in a regulated context.
Proficiency with reporting and visualization tools (Power BI, Tableau) and SQL for quality analytics.
Exposure to intelligent automation platforms (RPA, workflow automation) applied to quality operations.
Experience supporting regulatory inspections and external audits as a technology representative.
Familiarity with cloud platforms (Azure, AWS) and validated cloud application management.
Lean/Six Sigma, ASQ CQE/CQA, ITIL v4 Foundation, PMP, or relevant quality systems platform certification preferred.

Responsibilities

Develops tactical and operational plans to achieve quality systems technology goals, and communicates plans to managers, supervisors, and individual contributors.
Develops, owns, and executes the product roadmap for the enterprise quality systems portfolio, aligning platform capability to Quality and Regulatory strategy.
Prioritizes and maintains the backlog for assigned quality platforms, balancing the requirements of Quality process owners, Regulatory, Manufacturing, and Technology stakeholders.
Leads the product functional design process based on an intimate knowledge of quality system users, regulated processes, and platform technology.
Directs configuration, enhancement, and support of validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, document management, training records, and audit management.
Oversees analytics and reporting capability across quality data — defining metrics, dashboards, and trend analysis that give Quality leadership visibility into record aging, cycle time, and compliance posture.
Ensures all platform changes follow computer system validation, change control, and documentation requirements consistent with GxP, 21 CFR Part 11, and data integrity (ALCOA+) expectations.
Directs integration of quality systems with ERP (SAP), PLM, manufacturing execution, and post-market surveillance systems.
Identifies and delivers automation and AI-enabled improvement opportunities across quality processes, ensuring appropriate validation and human-in-the-loop controls.
Manages vendor and managed service partner relationships, including scope definition, quality of deliverables, and SLA performance.
Serves as the technology point of contact for internal, external, and regulatory audits and inspections, coordinating evidence, validation documentation, and remediation.
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.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))