Senior Clinical Quality Auditor
November 11
Description
• Shockwave Medical, Inc. is a pioneer in intravascular lithotripsy for complex cardiovascular disease treatment. • Senior Clinical Quality Assurance Auditor provides GCP compliance audits and vendor audits. • Responsible for audit findings, corrective actions, and regulatory inspections support. • Conduct internal and external audits according to GCP guidelines. • Training staff and writing SOPs as needed.
Requirements
• Bachelor’s Degree • 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
• Medical • Dental • Vision • Pre-tax and Roth 401k options with a fully vested match • Short-Term and Long-Term Disability • Life Insurance • Employer contribution toward Health Savings Account (HSA) • Competitive PTO balance • ESPP • Calm App • Pet Insurance • Student Loan Refinancing • Spot Bonus awards
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