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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:

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 needed based on investigation results including Failure investigations and Brand Protection assessments.

+ Collaborate with technical teams, subject matter experts, medical safety team, and manufacturing sites to ensure effective data analysis, comprehensive testingand timelyclosure of investigations.

+ Provide interdepartmental feedback to facilitate the resolution of product quality issues.

+ Provide support and execute equipment qualification, and test method validation.

+ Support equipment repairs, maintenance, and calibration activities, ensuring operational excellence across the organization. Perform Out of Tolerance (OOT) investigations for equipment as required.

+ Conduct non-conformance and Corrective and Preventive Actions (CAPA) investigations related to Complaint Investigation Laboratory issues.

+ Support internal and external audits.

+ Identify, plan, and implement key projects aimed at improving quality, reducing costs, increasing efficiency, and improving cycle time to drive business improvement and customer satisfaction.

+ Develop, improve, and update procedures and documentation including test methods, job aids, guidelines, and forms.

Qualifications:

Required

+ A minimum of aBachelor’sdegree or equivalent is required.

+ 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, 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)

Additional Information:

+ The expected base pay range for this position is $28 - $40 / hr.

+ The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

+ This position is overtime eligible. (include if applicable for role)

+ This position is eligible for a shift differential. (include if applicable for role)

+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

+ Employees may be 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.

+ Employees are eligible for the following time off benefits:

o Vacation –120 hours per calendar year

o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

o Holiday pay, including Floating Holidays –13 days per calendar year

o Work, Personal and Family Time - up to 40 hours per calendar year

o Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

o Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member

o Caregiver Leave – 10 days

o Volunteer Leave – 4 days

o Military Spouse Time-Off – 80 hours

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on July 9, 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

The anticipated base pay range for this position is :

$28 - $40 / hr

Additional Description for Pay Transparency: