Quality Engineering Manager

1 day ago

Santa Clara, California, United States Shockwave Medical Full time
Job Title: Quality Engineering Manager

Shockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Job Summary

The Quality Engineering Manager provides leadership for the Sustaining Quality Engineering and Complaint Investigation programs at Shockwave Medical. This role will be responsible for supporting both manufacturing operations and customer complaints. The successful candidate will have a strong understanding of medical device regulations and quality knowledge, with experience in investigating customer complaints and writing up complaint investigations.

Key Responsibilities
  • Ensure compliance with the Quality Management System (QMS) at Shockwave Medical.
  • Manage the Sustaining Quality Engineers and the Complaint Investigation Technicians within the Quality organization.
  • Provide guidance and assist in prioritizing the workload between complaints and manufacturing support.
  • Partner with Manufacturing and Operations teams to find solutions to technical problems.
  • Collaborate with Manufacturing Engineering to improve manufacturing processes and overall product quality.
  • Work with Sustaining Quality Engineers and Post Market Surveillance Team members to maintain and improve complaint closure rates.
  • Provide Quality Assurance leadership and guidance during product launches, process validations, and continuous improvement activities in a cross-functional environment.
  • Maintain audit readiness in all areas of responsibility.
  • Work with Quality Engineers to develop an audit program for auditing production lines and ensuring compliance to processes and procedures.
  • Maintain and manage the Servicing Program and coordinate servicing activities with internal and external parties.
  • Provide Quality Engineering support to the Manufacturing line and assist in maintaining validated processes.
  • Support Finished Goods Distribution and Commercial operations Quality activities.
  • Provide guidance to direct reports on non-conformances (NCRs).
  • Lead/support the completion of Quality Plans.
  • Drive assigned CAPAs to successful completion.
  • Assist in maintaining compliance with other areas of the QMS as needed (Non Conformance, Complaints, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.).
  • Develop, establish and maintain user-friendly process documents.
Requirements
  • Bachelor's Degree in an engineering discipline with 10 years' experience in Medical Device Quality, Manufacturing, or Engineering including 2+ years of supervisory experience.
  • Excellent understanding of medical device regulations with strong quality knowledge and experience.
  • Desire and ability to teach and convey standards and regulations to the organization.
  • Strong front room audit experience with an ability to effectively present and defend quality systems.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication and leadership skills.
  • Experience investigating customer complaints and writing up complaint investigations.
  • Strong background in statistics and statistical analysis.
  • 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.
  • Identifies and manages continuous improvement projects with the objective of achieving quality.
  • Responsible for coaching, training and development of subordinates.
  • Experience with software validation is preferred.
  • Must be willing work in a Class 100,000 (ISO Class 8) Cleanroom as necessary.
  • May be required to lift objects up to 25lbs.
  • May be required to travel 10% of the time (domestic and international).
Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

  • 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.
  • Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards.

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