Technology Mgr, Quality Systems, Analyst

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Job Function:

Technology Product & Platform Management

Job Sub Function:

Technical Product Management

Job Category:

People Leader

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

DePuy Synthes is recruiting for a Technology Mgr, Quality Systems, Analyst , located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN.

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.

Key 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.

Qualifications

Education:

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

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

Experience and Skills:

Required:

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.

Preferred:

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.

Other:

Travel: Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites.

Language: English   proficiency   required .

Certifications:   Lean /Six   Sigma,   ASQ CQE/CQA, ITIL v4 Foundation, PMP, or relevant quality systems platform certification preferred.

For more information on how we support the whole health of our employees throughout their wellness,   career   and life journey, please visit   www.careers.jnj.com .

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via  https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Analytical Reasoning, Consulting, Cost Management, Developing Others, Human-Computer Interaction (HCI), Inclusive Leadership, Leadership, People Performance Management, Performance Measurement, Product Development, Product Strategies, Project Management Methodology (PMM), Research and Development, Resource Management, Software Development Management, Strategic Supply Chain Management, Team Management

The anticipated base pay range for this position is :

102,000.00 - 204,000.00 USD

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits