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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:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Complaint Specialist II - Shockwave Medical to join our team located in Santa Clara, CA.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

In compliance with FDA, European MDD/MDR & other International Regulations, the Complaints Specialist II will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting, complaint follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. The Complaints Specialist II will also be responsible for filing MDR/MDV reports to applicable geography regulatory authorities, maintaining quality compliance, and ensuring quality metrics are achieved. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Under guidance, ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations.

• Initiate complaints and ensure all required information are gathered and added to the complaint file in an accurate and timely manner.

• Communicate with Customers and Shockwave Medical field reps in a timely and professional manner to gather necessary complaint information

• Coordinate the return of complaint devices for investigation (where applicable), and collaborate with the cross-functional engineers to ensure timely investigation and risk assessment of each complaint.

• Complete adverse event reporting determinations per geography regulatory requirements for approved devices (FDA, EU MDD/MDR, PMDA, TGA etc.) and route for approval in a timely manner.

• Escalate high risk incidents to management.

• Complete MDR/ MDV reports in an accurate and timely manner and ensure they are submitted to the regulatory authorities within the required timeframe per applicable geography regulation.

• Ensure compliance to the Post Market Surveillance System and prepare annual Periodic Safety Update Reports, PMS Reports, and other PMS Documents per geography regulatory requirements.

• Tracks regulatory changes in various geographies and update procedures accordingly

• Provide support of technical evaluations and investigational tasks to ensure complaints are investigated and closed in a timely manner.

• Write up complaint investigations using concise and grammatically correct English which is appropriate for regulatory review.

• Support service & repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.

• Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint initiation, reportability assessment, MDR/ MDV Reporting, and complaint closure.)

• Ensure complaints are prioritized based on the patient outcome, regulatory reporting requirements, product, and compliance risk.

• Participate in Customer and Shockwave Medical rep training to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements.

• Assist with reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.

• Participate in the summary and communication complaint trend data to cross-functional teams

• Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.

• Participate in quality system activities such as CAPAs, DCOs, and support internal and external audits.

• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.

• Other duties as assigned.

Requirements

• Associate’s degree with 4+ years of related quality experience or a Bachelor’s degree with 2+ years of related quality experience.

• Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices is required.

• Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.

• Proficiency in data compilation, analysis, presentation, and document writing skills.

• Excellent written and verbal communication skills.

• The ability to understand and follow QMS Procedures. (e.g., SOP and WI’s)

• Proficient with computer-based applications (MS Word, MS Excel, MS PowerPoint).

• Strong interpersonal skills and ability to provide good customer service support.

• Strong time management skills and the ability to multi-task in a fast-paced environment.

• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Pay Transparency:

• The anticipated salary range for this position is $73,000 - $117,300

• 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)).

• This position is eligible to participate in the Company’s long-term incentive program.

• 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

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

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

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 :

$73,000 - $117,300

Additional Description for Pay Transparency: