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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:
Johnson & Johnson is currently seeking a Complaint Investigation Specialist II to join our Johnson & Johnson Vision Complaint Investigation Lab located in Irvine, California.
The Complaint Investigation Specialist II 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 approving complaint investigations per company procedures and regulatory requirements. The Specialist II 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 II will also support equipment calibration, preventive maintenance, repairs, and qualifications. The Specialist II 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).
Review and approve complaint investigation results, ensuring compliance with regulatory requirements.
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 testing and timely closure of investigations.
Provide interdepartmental feedback to facilitate the resolution of product quality issues.
Lead daily workflow meetings, providing guidance and training within the department.
Execute and/or support equipment qualification, and test method validations activities and projects.
Manage 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 a Bachelor’s degree or equivalent is required.
A minimum of 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.
Experience with Complaint or NC/CAPA investigations.
Experience with equipment calibration, preventive maintenance, or qualification activities.
Ability to write and communicate clearly, including generating and presenting well-written reports
Preferred
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
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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$63,000-$102,350.00
Additional Description for Pay Transparency:
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. 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)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.