Quality Engineer

Johnson & Johnson MedTech; Jacksonville (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Quality Engineer for the Jacksonville, FL site. The role focuses on quality events, nonconformances, and applyingQuality Engineering tools to improve products and processes.

The engineer will support manufacturing and regulatory compliance, including FDA/ISO guidelines. Responsibilities include reviewing device history records, investigating issues, and driving corrective actions.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 0-2 years of related experience.
• Knowledge of product/process risk management (FDA and ISO standards).
• Experience working in a regulated/manufacturing environment is helpful.
• GMP/ISO regulations familiarity is beneficial.

Responsibilities

• Review device history records for quality standards and manage non-conformances.
• Conduct and support investigations to determine root causes and implement corrective actions.
• Support root cause determinations, material segregation, defect classification; apply new study designs.
• Ensure compliance with SOPs and regulatory requirements (FDA/ISO).
• Develop quality metrics and support continuous improvement in manufacturing processes.

Skills

Quality Assurance

Root Cause

GMP/ISO

Problem Solving

Risk Management

Education

Bachelor's degree in Engineering

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Job Sub Function

Job Category

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description

We are searching for the best talent for a Quality Engineer to be based in Jacksonville, FL.

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

Purpose:

The Quality Assurance Engineerassistswith quality events, nonconformances, and associated tasks at our Jacksonville Manufacturing site. TheyutilizeQuality Engineering tools and practices toeffectively and efficiently manage nonconformancesand ensure key metrics are met. They coordinate phases of work internally and externally. They apply Quality Engineering principles and problem-solving skills to enhance and sustain products and processes aligned with overall quality and business vision. Harsh environments andambiguous problems are managed to prevent unanticipated failure modes and improve process capability. This person will support processes inbasebusiness.

You Will Be Responsible For

• Responsible for review of electronic and/or manual device history records for quality standards andutilizesnon-conformance for document issues as needed.
• Conducts investigations, develops investigations, reviews and approves investigations, andinitiatesprojects designed to reduce recurrence.
• Supports investigations for root cause determinations, material segregation, classification of defect types including application of new techniques or study designs.
• EnsurescompliancetoSOPs and regulatoryrequirementsincluding FDA and ISO regulations.
• Executes quality tools and develops quality metrics for manufacturing processes and customer feedback.
• Acts as a change agent to improve compliance and quality culture.

Qualifications

Education:

• Bachelors or equivalent degree, preferably in Engineering or a related technical field.

Required

Experience and Skills:

• 0-2yearsof related experience.
• Knowledge of product/process Risk Management (FDA and ISO standards).

Preferred

• Experience working in a regulated environment is helpful.
• Experience working in a manufacturing environment is helpful.
• Ability to perform hands-on troubleshooting and problem solving is preferred. The ability to think on the feet andprovidingsound judgment is highly desired.
• The ability to perform hands-on troubleshooting and problem solving is helpful.
• Goodtechnical understanding of manufacturing equipment and processes is helpful.
• A thorough understanding of GMP/ISO regulations is helpful.

Other

• Shift position – C shift 6a-6pm

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.

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy