Shockwave Medical, Inc.
Manager, Quality Compliance
Shockwave Medical, Inc., Santa Clara, California, us, 95053
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 The Manager of Quality Compliance shall be responsible for ensuring compliance to regulatory requirements. The Manager of Quality Compliance shall be responsible for day-to-day operations of Non-conforming Reports (NCRs), Deviations, Rework, Final Lot release, Service Order Requests (SORs), and Quality Certificates processes. The Manager of Quality Compliance shall develop and implement procedures and systems to ensure Shockwave Medical, Inc. complies with applicable regulatory standards such as: ISO 13485 – Medical Devices – Quality Management Systems 21 CFR 820 Quality System Regulation and 21 CFR 803 Medical Device Reporting 2017/745 EU MDR – European Medical Device Regulation (EU MDR) Medical Device Single Audit Program Council of the European Communities Directive 93/42/EEC - Medical Device Directive Australia Therapeutic Goods (Medical Devices) Regulations 2002 Canadian Medical Device Regulations (SOR/98-282) Current Good Manufacturing Practices (CGMP) Quality Systems Regulation Other Regulatory and Industry Standards Responsible for direct supervision of Quality Compliance Team. Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements and company’s policies.
Identify changes to relevant regulatory requirements and industry standards Undertake gap assessment activities to newer regulatory requirements Work cross-functionally to address the identified system gaps and implement changes Train the organization to ensure the new requirements are communicated internally
Manage the NCR, Servicing, Deviation and Reworks System
Administer and manage the NCR/Servicing/Deviations/Rework logs and maintain overall compliance to relevant procedures Work cross-functionally with other teams to track and manage NCR/Servicing/Deviations/Rework activities from initiation through closure Lead the Material Review Board meetings Conduct periodic review of quality data for continuous improvements Collect and analyze data from various processes (NCR, RWR, DAs) for periodic reviews Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews Identify opportunities for improvement Present the information at the periodic reviews Monitor and trend metrics
Identify and drive Quality Management System continuous improvement activities Other relevant duties as assigned Requirements BS degree in a related discipline with 10+ years’ experience in medical device quality systems and compliance role 2 years of managerial experience or equivalent, relevant experience Strong understanding of FDA and other International medical device regulations Excellent written and verbal communication skills Experience in supporting International Regulatory Submissions Strong front room audit experience with an ability to effectively present and defend quality systems under your responsibility and management Proficiency in using Statistics, data compilation, analysis, presentation is preferred Project Management experience and excellent organizational skills is preferred RAPS RA certification is preferred Remains current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings Responsible for coaching, training and development of subordinates Identifies and manages continuous improvement projects Ability to work in a fast-paced environment while managing multiple priorities Operate as a team and/or independently while demonstrating flexibility to changing requirements Market Range:
$136,000 - $170,000 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
Description
Position Overview The Manager of Quality Compliance shall be responsible for ensuring compliance to regulatory requirements. The Manager of Quality Compliance shall be responsible for day-to-day operations of Non-conforming Reports (NCRs), Deviations, Rework, Final Lot release, Service Order Requests (SORs), and Quality Certificates processes. The Manager of Quality Compliance shall develop and implement procedures and systems to ensure Shockwave Medical, Inc. complies with applicable regulatory standards such as: ISO 13485 – Medical Devices – Quality Management Systems 21 CFR 820 Quality System Regulation and 21 CFR 803 Medical Device Reporting 2017/745 EU MDR – European Medical Device Regulation (EU MDR) Medical Device Single Audit Program Council of the European Communities Directive 93/42/EEC - Medical Device Directive Australia Therapeutic Goods (Medical Devices) Regulations 2002 Canadian Medical Device Regulations (SOR/98-282) Current Good Manufacturing Practices (CGMP) Quality Systems Regulation Other Regulatory and Industry Standards Responsible for direct supervision of Quality Compliance Team. Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements and company’s policies.
Identify changes to relevant regulatory requirements and industry standards Undertake gap assessment activities to newer regulatory requirements Work cross-functionally to address the identified system gaps and implement changes Train the organization to ensure the new requirements are communicated internally
Manage the NCR, Servicing, Deviation and Reworks System
Administer and manage the NCR/Servicing/Deviations/Rework logs and maintain overall compliance to relevant procedures Work cross-functionally with other teams to track and manage NCR/Servicing/Deviations/Rework activities from initiation through closure Lead the Material Review Board meetings Conduct periodic review of quality data for continuous improvements Collect and analyze data from various processes (NCR, RWR, DAs) for periodic reviews Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews Identify opportunities for improvement Present the information at the periodic reviews Monitor and trend metrics
Identify and drive Quality Management System continuous improvement activities Other relevant duties as assigned Requirements BS degree in a related discipline with 10+ years’ experience in medical device quality systems and compliance role 2 years of managerial experience or equivalent, relevant experience Strong understanding of FDA and other International medical device regulations Excellent written and verbal communication skills Experience in supporting International Regulatory Submissions Strong front room audit experience with an ability to effectively present and defend quality systems under your responsibility and management Proficiency in using Statistics, data compilation, analysis, presentation is preferred Project Management experience and excellent organizational skills is preferred RAPS RA certification is preferred Remains current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings Responsible for coaching, training and development of subordinates Identifies and manages continuous improvement projects Ability to work in a fast-paced environment while managing multiple priorities Operate as a team and/or independently while demonstrating flexibility to changing requirements Market Range:
$136,000 - $170,000 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