Complaint Investigation Specialist I

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:
US331 CA Irvine - 31 Technology Dr

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 Complaint Investigation Specialist I to be in Irvine, CA.

Intro to Role:  

The Complaint Investigation Specialist 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 Specialist 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 Complaint Investigation Specialist I will also support equipment calibration, preventive maintenance, repairs, and qualifications.

The Specialist I 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:  


* Evaluate and investigate customer complaints related to JJV product quality issues and concerns.  



* Review Device History Records (DHRs) and document findings in the JJV Complaint Handling System (CHS).  



* Perform product receiving and testing, documents result in a timely manner per applicable procedures. 



* For complaints involving External Manufacturers or Third-Party Manufacturers, conduct initial evaluations, product testing, and contact suppliers to ensure investigation timeliness. 



* Determine if further investigation activities are nee...