Manager, Quality Compliance

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.

• 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

Essential Job Function

• 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 continues 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

• BS degree in a related discipline with 10+ years' experience inmedical 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