Quality Compliance Specialist II- Shockwave

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Quality System Regulations (QSR) and FDA requirements, the Quality Compliance Specialist II supports product release and quality system activities by performing Lot History Record (LHR) and Lot Release Testing (LRT) documentation reviews to enable product release decisions. Performs work under supervision and follows established procedures to ensure documentation is complete, accurate, and aligned to procedures and release requirements; coordinates resolution of record discrepancies; and supports internal and external audits by preparing and presenting role-specific evidence. The position also supports quality record workflows including Deviations (DAs), Rework, and Nonconforming Records (NCRs), and collaborates cross-functionally to compile and trend quality data and generate periodic reports.

Essential Job Functions

• Perform Lot History Record (LHR) and Lot Release Testing (LRT) documentation reviews to support product release decisions.
• Review LHR/LRT documentation for completeness, accuracy, and alignment to procedures and release requirements.
• Coordinate resolution of record discrepancies, including documentation updates as needed, and follow up to drive timely completion.
• Support Deviation (DA) activities, including documentation, tracking, and timely closure.
• Support DA record documentation, tracking, and closure to meet timeliness expectations.
• Assist owners and cross-functional teams with investigation and disposition documentation, as applicable.
• Provide status updates and support data gathering for boards and reviews, as required.
• Support Rework activities, including documentation, tracking, and timely closure of Rework records.
• Coordinate with Operations/Manufacturing and Quality partners to ensure rework documentation supports product disposition and release.
• Support Nonconforming Records (NCRs) as needed, including NCR electronic transactions and routing.
• Compile data and prepare reports/presentations for periodic reviews of quality systems (e.g., NCRs, Deviations (DAs), Rework), as needed.
• Support internal and external audits by preparing and presenting role-specific evidence (LHR/LRT product release, Deviations (DAs), and Rework) and providing accurate responses to auditor questions.
• Interface with Subject Matter Experts (SMEs) as needed to obtain, clarify, and reconcile information within scope.
• 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 are met during Management Reviews
• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
• J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Other duties as assigned

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

Requirements

• Bachelor’s degree and 2+ years of related experience in the medical device (or other regulated) industry.
• Experience supporting product release activities, including LHR review and Lot Release Testing (LRT) documentation review.
• Experience supporting Deviation (DA) and Rework processes; NCR support experience is a plus (including electronic transactions/routing).
• Experience supporting FDA/ISO audits (preparing and presenting role-specific evidence).
• Strong ownership mindset for assigned projects/initiatives (drives work to closure, proactively removes barriers, escalates appropriately).
• Ability to compile, analyze, and trend quality data; able to create clear reports and presentations for stakeholders (e.g., Excel and PowerPoint).
• Competent technical/document writing skills; ability to understand and follow QMS procedures (e.g., SOPs, test methods).
• Excellent written and verbal communication skills; able to work cross-functionally with Operations/Manufacturing, Quality, and other partners.
• Basic knowledge of cGMP, FDA 21 CFR 820 QSR, and ISO 13485 (or equivalent Quality Systems).
• Proficiency with computer-based applications (MS Word, MS Excel, PowerPoint).
• Strong time management skills and ability to multi-task in a fast-paced environment.
• Ability to work independently and/or as part of a team, demonstrating flexibility to changing requirements.

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.

Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is :

$75,000.00 - $120,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits