Principal Quality Compliance Specialist

Quality Santa Clara, CA

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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.

Description  

Position Overview    

In compliance with FDA, European MDD/MDR & other International Regulations, the Principal Quality Compliance Specialist will perform work under minimal supervision. General scope of this position is to support final product release activities, non-conformance system management, CAPA, data analysis and continues improvements, support Quality system processes, internal and external audits, support External Standards management process and monitoring or key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, regulations 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 
  • Perform quality reviews of Production and Sterilization Records for accuracy, good documentation practice and compliance to respective procedures, and release final product to inventory  
  • Administer and manage the NCR/Deviations/Rework logs and maintain overall compliance to relevant procedures  
  • Process nonconforming reports from initiation through closure 
  • Participate in external and internal inspections/audits, assist in preparing, conducting the audits and following up on the audit findings. Assist in maintaining a constant state of inspection readiness 
  • Identify and process preventive and corrective actions 
  • Compile, analyze and report QMS metrics on a routine basis 
  • Prepare and support Management Review Reports and KPI reporting 
  • Review, maintain and approve Quality System documents, records and reports including nonconformance 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. 
  • Assist in mentoring and training others 
  • Support company goals and objectives, policies, and procedures, QSR, and FDA regulations 
  • Identify and drive Quality Management System continuous improvement activities
  • Other duties as assigned

Requirements   

  • Bachelor’s degree and 10+ years of quality related experience in the Medical Device industry 
  • Excellent working knowledge of current USA Food and Drug Administration (FDA), ISO13485, MDR and other global laws, regulations and standards 
  • Ability to perform Internal Audits 
  • Strong background in administering and processing NCRs and CAPAs 
  • 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 
  • 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: $121,000 - $151,000
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  

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