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 Quality Compliance 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 & ISO regulations, the Quality Compliance Specialist will perform work under supervision. General scope of this position is to support NCR process, CAPA process, internal and external audits, data analysis and monitoring of the of key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Assist with audit activities.

  • Participate in quality system activities and support internal and external audits as a Subject Matter Expert (SME) for NCR and CAPA Processes

  • Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channel etc.)

  • Interface with Subject Matter Experts regarding the audit requests

• Manage the NCR/Rework System

  • Work cross-functionally with other teams to track and manage NCR/Rework/Deviation activities from initiation through closure

  • Assist with affected product identification, segregation, investigation and final disposition

  • Conduct periodic meetings of the Material Review Board (MRB) to present NCR trends, reports and any additional data analysis as requested

  • Identify and implement QMS system continuous improvement activities to the NCR process

  • Maintain NCR procedures and records per procedure requirements

• Manage CAPA process

  • Work cross-functionally with other teams to track and manage CAPA activities from initiation through closure

  • Assist CAPA Owners with CAPA initiation, root cause investigation, CAPA actions development, tracking of CAPA actions to completion, effectiveness plan developments, review and closure of CAPA records

  • Conduct periodic meetings of the CAPA Board to present new CAPAs, status of active CAPAs, CAPA trends, reports and any additional data analysis as requested

  • Identify and implement QMS system continuous improvement activities

  • Maintain CAPA procedures and records per procedure requirements

• Compile quality metrics for trending purposes

  • Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: NCRs, CAPAs, Rework, etc.

• Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality systems activities

  • Work cross-functionally with other teams in tracking and ensuring Quality Objectives published during Management Reviews are met

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

  • Other duties as assigned

Requirements

• Bachelor’s degree and a minimum of 2+ years of related experience in the medical device industry.

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

• Ability to compile and analyze data, present information, and demonstrate competent document writing skills.

• Excellent written and verbal communication skills.

• Basic knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.

• The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.)

• Experience with computer-based applications (MS Word, MS Excel, Power Point).

• 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.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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:

$86, 700 - $117, 300

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)). 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 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.