The Role
Directs quality assurance operations for a medical device manufacturing site, overseeing quality systems, inspections, testing, material release, quality engineering, audits, regulatory compliance, and inspection readiness. Develops site quality strategy, supports FDA communications, leads quality-system improvements, manages risks and nonconforming materials, and reports to executive leadership. The role also oversees staff development, succession planning, budgeting, and cross-functional collaboration with supply chain, operations, engineering, production planning, logistics, and product management.
Summary Generated by Built In
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 MedTech, 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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Jacksonville, Florida, United States of AmericaJob Description:
Job Position SummaryDirects the Jacksonville - FL, Johnson and Johnson Surgical Vision Quality Operations organization, ensuring compliance with quality requirements, continuous supply to customers, compliance and regulatory agencies requirements, among others. Responsible for taking a leadership role in defining short and long-term strategies for the Jacksonville facility.Has direct accountability through direct reports, over inspection and release of incoming raw materials, in-process and final Quality inspection and testing. Directs the Quality Engineering team and Quality Systems site execution. Engages and collaborates with Franchise Quality teams as well as cross functional Supply Chain functions including Operations, Makes Engineering, Production Planning and Logistics and Product management to assure a horizontal approach to resources management and prioritization.Duties & Responsibilities1. Serves as local Quality Systems Management Representative for the Jacksonville IOL site.2. Operates tactically within the operations environment to ensure practical and timely provision of Quality decision making. Oversees management of the day-to-day quality activities related to the Jacksonville site. Makes decisions on non-conforming material, as required by the Quality System procedures. Evaluates and communicates quality events for elevation to Risk Management Board and/or Quality Board as per applicable procedures.3. Develops the site operational Quality strategy as a business partner to Supply Chain Operations and Franchise QA functions to optimize the performance of operations, compliance, and quality systems as well as influence the global integration and alignment of goals across the organization.4. Serves as Host for 3rd party audits; participates and presents in Quality and Compliance Executive Reviews, Management Reviews, Quality Boards and others as requested/required.5. Reports to Executive Management on the effectiveness of the Quality Management System and any need for improvement.6. Ensure the promotion of awareness of applicable regulatory requirements and Quality Management Systems requirements throughout the organization.7. Ensures that processes needed for the Quality Management System are documented.8. Evaluates Jacksonville’s Quality Operations capabilities, identify gaps, and recommends issue resolution to Executive Management. Develops and leads innovative initiatives to improve business performance to support visionary changes.9. Provides coaching and staff development, manage performance, succession planning, and departmental budget. Is accountable for organizational capabilities to meet current and future business needs.10. Serves as a technical expert for functional area, with conceptual knowledge of all quality functions and business areas.11. Serves as Subject Matter Expert (SME) for execution of Quality Systems in Jacksonville during inspection readiness activities. Supports the preparation of any communications with FDA related to any follow-ups of inspections carried out at the Jacksonville site.12. Directly supports the design and deployment of Quality Systems improvements, standards and policies at site level.13. Observes all Company’s Environmental, Safety, and Industrial Hygiene policies and regulations.
Experience & Education· Bachelor’s Degree - Science/Engineering. MBA preferred.· 15 years of experience in the Medical Devices or Pharmaceutical sector, with a minimum of 7 years of managerial experience and 5 years in Quality.· Experience with FDA/Notified Body agencies. Regulatory experience, including US Class III (PMA) and US Class II regulations, supporting timely and compliant regulatory submissions, inspections and audits.
Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations· Thorough knowledge of 21 CFR 820.· Demonstrated success in the design and deployment of innovative quality systems.· Ability to influence at senior levels and across functions building strong networks internally and externally. Experience delivering results through influence in a highly matrix environment.· Strong experience and proven record motivating, leading and developing staff, in a highly changing environment.· Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control and Applied Statistics. Six Sigma.
Location & Travel RequirementsLocation: JJSV Jacksonville FL
Travel:20%
Required Skills:
Preferred Skills:
Business Alignment, Collaboration, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical CredibilityThe anticipated base pay range for this position is :
$122,000.00 - $212,750.00Additional 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)).This position is eligible to participate in the Company’s long-term incentive program.
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
Skills Required
- Bachelor’s degree in Science or Engineering
- MBA
- 15 years of experience in the medical device or pharmaceutical sector
- At least 7 years of managerial experience
- At least 5 years of quality experience
- Experience with FDA and Notified Body agencies
- Regulatory experience supporting US Class III PMA and US Class II submissions, inspections, and audits
- Thorough knowledge of 21 CFR 820
- Demonstrated success designing and deploying quality systems
- Ability to influence senior leaders and work across functions in a matrix environment
- Experience motivating, leading, and developing staff
- Understanding of Process Excellence, Statistical Process Control, and Applied Statistics
- Six Sigma experience
- Business alignment and collaboration
- Compliance management and quality auditing
- Good Manufacturing Practices (GMP) and ISO 9001 knowledge
- Quality Control, Quality Management Systems, and Quality Validation knowledge
- Knowledge of regulatory environments and Standard Operating Procedures
- Mentorship, fact-based decision making, tactical thinking, and technical credibility
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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The Company
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
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