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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 https://www.jnj.com

Job Function:

Quality

Job Sub** **Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

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

We are searching for the best talent for **Customer Complaint Engineer I** to be in **Jacksonville, Florida** .

Intro to Role:

The **Cus** **t** **omer** **Complaint Engineer I** reports to the Manager, Surgical Vision Complaint Investigations, and plays a pivotal role in ensuring effective and thorough handling of customer complaints. This position is responsible for evaluating, documenting, and completing complaint investigations per company procedures and regulatory requirements. The Engineer I will routinely engage in product receiving, testing, investigations, updates, and file closure within the JJV Complaint Handling System (CHS). A core aspect of this role involves collaborating with technical teams, subject matter experts, the medical safety team, and manufacturing sites to conduct comprehensive complaint investigations.

The Engineer will also complete equipment calibration, preventive maintenance, repairs, qualifications, test method validation, and Out of Tolerance (OOT) investigations as required. The Engineer will participate in internal and external audits, conduct Non-Conformance (NC) and/or Corrective and Preventive (CAPA) investigations as needed, and contribute to compliance and process improvement.

This role presents an excellent opportunity to impact the integrity of complaint handling processes while building strong collaborative relationships across departments.

Responsibilities/Principal Duties** **:

+ Conducts and leads complaint investigations related activities (i.e., Device History Records (DHRs), Complaint History Review (CHR), product receiving and testing, documents result in CHS, among others).

+ Evaluates and investigates customer complaints for JJV product quality issues and concerns.

+ Determine if further investigation or escalation activities are required based on complaint investigation results.

+ Ensure that all complaint and failure investigations results are documented in a timely manner following the applicable procedures.

+ Assists to identify corrective and preventative actions based on failure investigations root cause.

+ Partners with technical teams/subject matter authorities, medical safety team, manufacturing sites to ensure sound experimental design, effective data analysis, and subsequent closure of investigations. In addition to improve test methods, procedures, and tools for product evaluation activities.

+ For External Manufacturers / Third Party Manufacturer complaints - perform initial evaluation, product testing and contact suppliers for complaint investigation activities, as applicable.

+ Monitors and compiles monthly complaint data, metrics, and identifies product quality trends.

+ Provides interdepartmental feedback for investigation and resolution for product quality issues.

+ Performs equipment qualification, and test method validations activities.

+ Performs non-conformance and CAPA investigations related to Complaint Laboratory issues.

+ Support internal/external audits including Subject Matter Expert (SME) Complaint Laboratory representative, observation investigations, provide walk-through tours, among others. Support Environment, Health, and Safety (EHS) requirements and compliance.

+ Maintain preventive maintenance and calibration activities for laboratory equipment. Perform OOT investigations for equipment as required.

+ Identify, plan, and implement key projects to improve quality, reduce costs, increase efficiency, and improve cycle time by reducing wasted time, rework, etc. resulting in significant business improvement and customer satisfaction.

+ Develop, improve, or update procedures and documents (including test methods, job aids, guidelines, forms).

+ Supports continuous improvement initiatives within the laboratory and overall business.

Qualifications:

Required

+ University Degree Required (B.A., B.S., B.E. preferred)

+ 0 - 2 years of experience in Medical Device and/or Pharmaceutical industry with responsibilities in Quality.

+ Knowledge and understanding of FDA, EU, and applicable worldwide regulations, standards and guidelines pertaining to safety of drugs and/or devices.

+ Ability to write and communicate clearly, including generating and presenting well-written reports.

Preferred

+ Experience with Complaint or NC/CAPA investigations.

+ Experience with equipment calibration, preventive maintenance, and/or qualification activities.

+ Basic project management skills and project leadership abilities.

+ Proven ability to work effectively with multi-functional teams for complaint investigation and root cause analysis.

+ Demonstrated critical thinking, and problem solving.

Other

+ Travel – 10% (National)

This job posting is anticipated to close on July 22, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource