Sr. Clinical Quality Auditor- Shockwave Medical; Remote

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

All Job Posting Locations: Santa Clara, California, United States of America

Johnson & Johnson is hiring for a Sr. Clinical Quality Auditor – Shockwave Medica to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

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.

The Sr. Clinical Quality Auditor will provide GCP and compliance-related audits of internal and external Clinical Studies in process, support updates of procedures in compliance with applicable regulations and perform vendor audits as needed.

• Act as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices.
• Support development of audit management plans and audit strategy for ongoing clinical trials.
• Conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
• Participate in the development of departmental standard operating procedures, work instructions, forms, and templates.
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented.
• Support or conduct training for staff (GCP, Inspection Readiness training, etc.).
• Support regulatory inspections.
• Review/revise Standard Operating Procedure (SOPs) and procedures as assigned.
• Responsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as needed.
• Identify and escalates site, vendor and study related issues to management, as appropriate.
• Work independently once projects are assigned.
• Other duties as assigned.

• Bachelor’s Degree or equivalent experience in a scientific field of study.
• 5 years’ experience directly supporting clinical research, QA, or relevant experience in medical/scientific area.
• Experience conducting audits of vendors and investigative sites.
• Experience interacting with regulatory authority inspectors.
• Experience preparing and supporting clinical study sites undergoing regulatory authority inspections.
• Experience revising SOPs and procedures.
• Thorough knowledge and application of Good Clinical Practice (GCP) is required, i.e. FDA, ISO 14155, MDR.
• Independent thinking and planning ability.
• Medical Device experience preferred.
• Ability to travel up to 30%-40% domestically and internationally.
• Excellent written and verbal communication skills.
• Exceptional teamwork skills.
• Basic understanding of peripheral and coronary artery disease and therapies preferred.
• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required.
• ACRP or SOCRA certification preferred.
• Ability to work in a fast‑paced environment while managing multiple priorities across multiple projects.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• High attention to detail and accuracy.

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail‑Oriented, Goal Attainment, Human‑Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

The anticipated base pay range for this position is: $91,000.00 - $

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…