Principal Quality Systems Specialist

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

In compliance with FDA, European MDD/MDR & other International Regulations, the Principal Quality Systems Specialist will perform work under minimal supervision. General scope of this position is to support Quality system processes implementation, maintenance and improvements, new geography’s implementation activities, support development and implementation of quality objectives, Management Reviews, internal and external audits, CAPA process, support External Standards management process including compiling quality metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Assist in developing, administering, and maintaining quality system procedures and activities to ensure that the SWMI processes and products follow applicable quality standards and requirements
• Participate in external and internal inspections/audits, assist in preparing, conducting the internal audits, and following up on the audit finding actions. Assist in maintaining a constant state of inspection readiness throughout al QMS
• Identify and process corrective and preventive actions, work with SMEs on implementation and closure of CAPAs
• Prepare and analyze routine QMS metrics and reporting
• Prepare and support Management Review Reports and KPI reporting
• Review, maintain and approve Quality System documents, records and reports including non-conformances and CAPA records, standards change requests, trending reports, and others as assigned
• Lead improvement projects to completion that may be initiated from non-conformances, audits, etc.
• Support implementation of new products and new country’s requirements within the SWMI QMS activities by evaluating new country regulatory requirements and implementing new requirements in SWMI QMS processes and procedures
• Develop and implement Standards and Regulation tracking and information collection tools, maintain Standards logs with current revisions of the standards, and report on progress of implementation
• Other duties as assigned

Requirements

• AA degree with 15 years of related quality experience in the medical device industry or Bachelor’s degree with 10+ years of related quality experience in the medical device industry
• Excellent working knowledge of current FDA, ISO13485, MDR and other global laws, regulations and standards
• Ability to perform internal audits
• A commitment to quality and a high level of self-motivation
• Problem solving capability, ability to drive implementation of root cause identification and corrective actions
• Excellent verbal and written communications skills
• Strong interpersonal skills and an ability to work as an effective member of a cross-functional team
• Excellent organizational skills and high attention to detail
• Proficiency in data compilation, analysis, presentation, and document writing skills
• Familiarity with statistical data analysis tools and concepts
• Ability to work independently
• Excellent working knowledge of computer-based applications (MS Word, MS Excel, QAD)
• 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

Market Range: $114,166 - $144,235
Exact compensation may vary based on skills, experience, and location.

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