Job Function:
Supply Chain Engineering
Job Sub Function:
Quality Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Memphis, Tennessee, United States of America
Job Description:
Johnson & Johnson is recruiting for a Sr. Quality Engineer, to be located in Memphis, TN.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at
https://www.jnj.com/medtech
The Sr. Quality Engineer is accountable for shaping and sustaining a compliant, efficient, and continuously improving Quality System within the Memphis Logistics Center (MLC). This role connects cross-functional partners, including Operations, Quality Systems, and 3PL providers—to ensure alignment with Enterprise, Sector, and Deliver strategies while safeguarding product quality and patient safety.
Through strong ownership and leadership, this position drives data-based decision making, problem solving, and process improvements that enhance compliance, reduce risk, and optimize cost and service performance. The Sr. Quality Engineer is responsible for delivering business impact by strengthening quality culture, ensuring inspection readiness, and leading initiatives that improve end-to-end distribution quality outcomes.
This role holds end-to-end accountability for Cold Chain Quality operations, ensuring the integrity, control, and compliance of temperature-sensitive products throughout storage and distribution. This includes establishing and enforcing robust controls for temperature monitoring, excursion management, labeling accuracy (including date/time requirements), process validation, and audit readiness. The Sr. Quality Engineer proactively identifies and mitigates risks, drives continuous improvement in Cold Chain processes, and ensures full compliance with regulatory requirements and internal standards to protect product quality and patient safety.
Key Responsibilities:
- Establish, maintain, and continuously improve Quality Assurance systems and processes supporting distribution operations
- Design and evaluate sampling plans, inspection methods, and process control strategies
- Serve as process owner for document control (Windchill) and ensure robust documentation practices
- Provide Quality and Compliance oversight for the 3PL distribution partner, ensuring adherence to internal standards and regulatory requirements
- Build strong partnerships that promote accountability and shared ownership of quality outcomes
- Ensure the Quality Management System (QMS) remains compliant with 21 CFR Part 820, ISO 13485, and other global regulations
- Lead and support internal audits, external inspections, and audit readiness activities
- Lead investigations into nonconformances, CAPAs, and customer complaints, ensuring timely and effective resolution
- Perform root cause analysis and implement corrective and preventive actions to prevent recurrence
- Analyze quality data and trends to identify risks and improvement opportunities
- Support cold chain quality requirements, including verification processes and internal audits
- Manage restricted inventory and product disposition, driving timely release of aging product
- Provide quality oversight and technical support for new process transfers into MLC operations
Qualifications
Education:
- Bachelors or equivalent degree in Engineering, Quality, Life Sciences, or a related technical discipline
Experience and Skills:
Required:
- Minimum 4-6 years of experience in Quality, Engineering, or Compliance within a regulated industry (e.g., medical device, pharmaceuticals, healthcare)
Strong working knowledge of:
- Quality Management Systems (QMS)
- CAPA, Nonconformance, and Root Cause Analysis methodologies
- Global regulatory standards (e.g., 21 CFR Part 820, ISO 13485)
- Experience supporting distribution, warehouse, or logistics operations, including process controls
- Demonstrated ability to analyze data, identify trends, and drive data-based decisions
- Strong written and verbal communication skills, with the ability to influence cross-functional stakeholders
Preferred:
- Experience with Warehouse Management Systems
- Experience with Temperature Control Transportation
- Experience working with or providing oversight to third-party logistics (3PL) providers
- Knowledge of cold chain and controlled warehouse environments
- Experience with document control systems (e.g., Windchill)
- Lean, Six Sigma, or Continuous Improvement certification (Green Belt or higher preferred)
- Experience supporting regulatory inspections and audit readiness activities
- Familiarity with global regulatory requirements (e.g., MDR/MDD, CMDR, TGA, ANVISA, MHLW)
Other:
- Proficiency (oral & written) in the English language is required
- Up to 10% travel may be required
Required Skills:
Preferred Skills:
Consistency, Consulting, Controls Compliance, Data Savvy, Developing Others, Good Automated Manufacturing Practice (GAMP), Inclusive Leadership, ISO 9001, Leadership, Lean Supply Chain Management, Leverages Information, Project Engineering, Quality Control Testing, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supply Planning, Team Management
