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Senior Quality Manager

Job in Irving, Dallas County, Texas, 75084, USA
Listing for: Johnson & Johnson MedTech
Full Time position
Listed on 2025-12-21
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at

Johnson & Johnson is currently recruiting a Senior Quality Manager to join our Aesthetics & Reconstruction (A&R) organization in Irving, Texas. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, and more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at

Job Responsibilities Supplier Quality Leadership
  • Implement and maintain Purchasing Control processes for suppliers and external manufacturing operations.
  • Manage supplier‑related quality systems, including:
    • Change Control
    • NC/CAPA management
    • Quality Agreements
    • Specification development
    • Supplier Selection & Qualification
    • Approved Supplier List
  • Drive identification and mitigation of supplier‑related risks to improve reliability and performance.
  • Track and trend key quality indicators/metrics to monitor supplier and QMS performance.
  • Lead, develop, and mentor a high‑performing team of Supplier Quality Engineers.
  • Partner with internal customers (Sourcing, Planning, QA, Operations, R&D, Regulatory, Distribution, Marketing, etc.) and suppliers and/or external manufacturers to ensure compliance to product requirements, material/component specifications, company procedures, FDA, ISO, etc.
  • Support audits and inspections related to supplier quality.
Strategy & Deployment Leadership
  • Translate A&R Quality strategic priorities into clear, executable roadmaps.
  • Lead cross‑functional deployment of initiatives, ensuring alignment with business, quality, and compliance goals.
  • Establish governance routines, performance dashboards, and KPI tracking for strategic projects.
  • Drive change management and stakeholder engagement to ensure adoption of new processes and systems.
  • Collaborate with global and regional teams to maintain alignment and consistency in execution.
  • Track and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans and communicating business‑related issues or opportunities to management.
Qualifications Education
  • A minimum of a bachelor’s degree in engineering or science discipline is required.
Required
  • A minimum of 10 years of related experience with at least 4 years people‑management experience (ideally in medical device).
  • Experience working within a GXP environment and with international standards/requirements including but not limited to EN/ISO 13485, 21 CFR Part 820/11, ISO 14971, EUMDR, Canadian Medical Device Regulations (SOR/98‑282), and other necessary medical device regulations and standards appropriate for this role.
  • Demonstrated knowledge of manufacturing principles and practices, and procedures.
  • Component qualification / process validation experience.
  • Consistent track record on continuous improvement initiatives and improvement methodologies.
  • Prior manufacturing, plant, or technical background.
  • Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls.
  • Demonstrated ability to identify compliance risks and assess business impact.
  • Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches.
  • Ability to manage complexity and lead a diverse team is essential.
Preferred
  • Advanced degree.
  • Project Management Certification.
  • Prior experience with FDA and/or Notified Body inspections.
  • Direct experience with supplier GMP audits.
  • Track record with supporting intercompany and/or working closely with external suppliers on major compliance initiatives.
  • Green Belt or higher rank and/or…
Position Requirements
10+ Years work experience
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