-
Compliance Specialist
1 week ago
Pacific Gas & Electric CO San Jose, United StatesThe Public Safety & Regulatory Department contributes to public safety through the planning, scheduling, and execution of the annual General Order (GO) 165 patrol, inspection, and corrective maintenance program. The PS&R Specialist performs day-to-da Compliance Specialist, Compli ...
-
Compliance Specialist
1 week ago
Pacific Gas And Electric Company San Jose, United StatesRequisition ID# 158045 · Job Category: Administrative / Clerical · Job Level: Individual Contributor · Business Unit: Electric Operations · Work Type: Hybrid · Job Location: San Jose · Position Summary · The Public Safety & Regulatory Department contributes to public safety throu ...
-
HR Compliance Specialist
15 hours ago
Sustainable Talent Limited Liability Company Santa Clara, United StatesJob Description · Job DescriptionSustainable Talent is partnering with Nvidia a global leader who's been transforming computer graphics, PC gaming, and accelerated computing for over 25 years. · We are looking for an HR Compliance Specialist to support our client's HR Global Com ...
-
Compliance Program Specialist
1 week ago
Bayside Solutions Cupertino, United StatesCompliance Program Specialist · W2 Contract · Salary Range: $83,200 - $93,600 per year · Location: Remote Role · Job Summary: · We are seeking an individual who is comfortable working in collaborative environments with minimal formal structure and can adapt to changing environmen ...
-
Security Compliance Specialist
1 week ago
Vets Hired San Jose, United StatesAbout the job Security Compliance Specialist · Responsibilities: · Support the maintenance of strong governance, risk, and the compliance process for ISO · Continuously improve the security framework, methodology, standards, and system of internal controls. · Govern the NCR p ...
-
Security Compliance Specialist
3 weeks ago
Vets Hired San Jose, United StatesAbout the job Security Compliance Specialist · Responsibilities: · Support the maintenance of strong governance, risk, and the compliance process for ISO 27001. · Continuously improve the security framework, methodology, standards, and system of internal controls. · Govern the N ...
-
Environmental Compliance Specialist
2 weeks ago
Support Revolution San Jose, United StatesPress Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Create Alert · Select how often (in days) to receive an alert: · Location: · San Jose, California, United States · About Supermicro: · Supermicro is a Top Tier provider of advanced se ...
-
Environmental Compliance Specialist
1 week ago
Super Micro Computer, Inc. San Jose, United StatesJob Req ID: 24041 · About Supermicro: · Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing c ...
-
Environmental Compliance Specialist
2 weeks ago
Support Revolution San Jose, United StatesPress Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertSelect how often (in days) to receive an alert:Location: San Jose, California, United StatesAbout Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and ne ...
-
Regulatory Affairs Compliance Specialist
1 day ago
INTELLECTT INC Santa Clara, United StatesHello, · I Hope you are doing great. · This is · Bhanu · from Intellectt INC; we've got an important role · Regulatory Affairs Compliance Specialist · - · Santa Clara, CA · with one of our prestigious clients. Interested candidates can please send your updated resume at ...
-
Compliance Specialist
2 weeks ago
PG&E Corporation SAN JOSE, United StatesRequisition ID # · Job Category: Administrative / Clerical · Job Level: Individual Contributor · Business Unit: Electric Operations · Work Type: Hybrid · Job Location: San Jose · Position Summary · The Public Safety & Regulatory Department contributes to public safety through ...
-
Sanctions Compliance Specialist
2 weeks ago
Gateway Recruiting San Jose, United StatesAssist Global Export and Sanctions Compliance team members in sanctions compliance activities by:Conduct reviews and investigations to appropriately resolve potential matches generated by the sanctions systemConduct investigation of customers, business partners, and transactions ...
-
Compliance Specialist 3
2 days ago
ACL Digital Sunnyvale, United StatesPrimary Function of Position: · The Compliance Specialist 3 will implement and execute to an efficient, effective and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes evaluating the relevance to all ISI f ...
-
Paralegal - Compliance Specialist
4 days ago
Spring Education Group Campbell, United States Full time· Paralegal - Compliance Specialist · Spring Education Group (CA), 1999 S Bascom Ave, Campbell, California, United States of America ● Virtual · Req #6504 · Monday, June 17, 2024 · Spring Education Group is a multi-brand education network of superior private school institutions ...
-
HR Compliance Specialist
2 weeks ago
Sustainable Talent Limited Liability Company Santa Clara, United StatesJob Description Job Description Sustainable Talent is partnering with Nvidia a global leader who's been transforming computer graphics, PC gaming, and accelerated computing for over 25 years.We are looking for an HR Compliance Specialist to support our client's HR Global Complian ...
-
Amazon Santa Clara, United StatesDo you have experience obtaining and maintaining IT compliance certifications for your organization? Do you have experience performing internal or external IT audits and assessments? Do you see regulatory compliance as a business enabler? Buy with Prime and Multi-Channel Fulfillm ...
-
Global Q&R Compliance Training Specialist
1 week ago
Apollo Professional Solutions Santa Clara, United StatesJob Description · Description:Hybrid Position in Branchburg, NJ - Local Candidates · As the Global Q&R Compliance Training Specialist, you will be a member of the Global Q&R Compliance Training Chapter. · In this position, you will possess capabilities in development/implementat ...
-
Affordable Compliance Specialist
2 weeks ago
Equity Residential San Jose, United StatesWorking for Equity Residential means being part of a community and striving to provide the best in apartment living, speaking boldly about new ideas for innovation, and inspiring creativity in the ways we work together. Thats what our Be.Think.Play.Live. culture is all about. · ...
-
Affordable Compliance Specialist
3 weeks ago
Equity Residential San Jose, United StatesWorking for Equity Residential means being part of a community and striving to provide the best in apartment living, speaking boldly about new ideas for innovation, and inspiring creativity in the ways we work together. Thats what our Be.Think.Play.Live. culture is all about.The ...
-
Environmental Compliance Specialist
2 weeks ago
Super Micro Computer, Inc. San Jose, United StatesJob Req ID: 24041 · About Supermicro: · Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing c ...
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
#J-18808-Ljbffr
