Senior Clinical Quality Auditor

Description

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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

The Sr. Clinical Quality Assurance 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. This work is accomplished with moderate oversight, requires frequent contact with internal and external customers and is critical to the success of the business. 

• 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 and in alignment with internal audit plans
• 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
• Identifies and escalates site, vendor and study related issues to management, as appropriate
• This work is accomplished with moderate supervision and requires a motivated, self-starter who can 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 is preferred
• Ability to travel up to 30%-40% of time domestically and internationally
• Excellent written and verbal communication skills
• Exceptional teamwork skills
• Requires a motivated, self-starter who can work independently once projects are assigned
• 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
• Must have excellent verbal and written communication skills 
• High attention to detail and accuracy

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer