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Principal Quality Compliance Specialist - Santa Clara, United States - Shockwave Medical
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
Bachelors 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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