Current jobs related to Clinical Quality Assurance Manager - Santa Clara, California - Shockwave Medical

  • Clinical Quality Assurance Manager

    4 weeks ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job SummaryShockwave Medical is seeking a highly experienced Clinical Quality Assurance Manager to join our team. As a key member of our clinical affairs department, you will be responsible for providing GCP and compliance-related oversight and audit of internal and external clinical studies. This role requires a strong understanding of regulatory standards...

  • Quality Assurance Manager

    4 weeks ago

    Santa Clara, California, United States Bayside Solutions Full time

    Quality Control SupervisorAt Bayside Solutions, we are seeking a highly skilled Quality Control Supervisor to join our team. As a key member of our quality assurance team, you will be responsible for developing and implementing quality control testing and product inspection at various production stages.Key Responsibilities: Develop and implement quality...

  • Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States QualiTest Group Full time

    Quality Assurance SpecialistAt QualiTest Group, we are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have a strong understanding of software development methodologies and processes, as well as experience in IT quality assurance best practices.Key Responsibilities:⁠ Develop and implement quality assurance processes and...

  • Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States AdvancedPCB Full time

    Job DescriptionAt AdvancedPCB, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for managing the operation of the document control center to ensure adherence to AS9100, UL, and other industry and regulatory standards.Key Responsibilities:Manage AS9102 form, Discus...

  • Software Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States Della Infotech Full time

    The Software Quality Assurance Engineer at Della Infotech is responsible for ensuring the quality of the daVinci Product (Simulator) software.This position requires a strong QA and manual software test background, as well as experience with clinical verification/validation of products, coding skills for automated test scripts, and documentation skills for...

  • Senior Director of Quality Assurance

    3 weeks ago

    Santa Clara, California, United States Astera Labs Inc. Full time

    At Astera Labs Inc., we are seeking a highly skilled Senior Director of Quality Assurance to lead our quality organization to success. The ideal candidate will have a strong background in quality assurance, with a proven track record of driving quality excellence in complex product environments.The Senior Director of Quality Assurance will be responsible for...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States QualiTest Group Full time

    Quality Assurance SpecialistAt QualiTest Group, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for consulting, recommending improvements, and implementing Quality Assurance Processes and Procedures based on IT Quality Assurance best practices and industry standards.Key...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States QualiTest Group Full time

    Quality Assurance Role OverviewAt QualiTest Group, we are seeking a highly skilled Senior Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and a proven track record of implementing quality processes and procedures.Key Responsibilities:Consult with stakeholders to identify quality...

  • Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States Intellectt Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Intellectt Inc. As a Supplier Quality Engineer, you will play a critical role in ensuring the quality of our suppliers and driving process improvements.Key ResponsibilitiesCollaborate with cross-functional teams to identify and resolve quality issues.Conduct root...

  • Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States Jobot Full time

    Job Title: Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to join our team at Jobot. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality, reliability, and performance.Responsibilities:* Lead the quality assurance inspection team and oversee the...

  • Quality Assurance Specialist

    1 month ago

    Santa Clara, California, United States Aerotek Full time

    Job Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at Aerotek. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Generate detailed and accurate inspection and testing reports, and maintain...

  • Electrical Quality Assurance Specialist

    4 weeks ago

    Santa Clara, California, United States FST Technical Services Full time

    FST Technical Services is a leading provider of quality assurance solutions in the Semiconductor and Microelectronics Industry. We are seeking a highly skilled Electrical Quality Assurance Specialist to join our team in Santa Clara, CA.The successful candidate will be responsible for overseeing the work performance of sub-contractors to ensure compliance...

  • Software Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States Della Infotech Full time

    Job SummaryThe Software Quality Assurance Engineer is responsible for ensuring the quality of the daVinci Product (Simulator) software. This position requires a strong QA and manual software test background, with experience in clinical verification/validation of products, coding skills for automated test scripts, and documentation skills for test...

  • Quality Assurance Specialist

    1 month ago

    Santa Clara, California, United States Workers Full time

    Job OverviewWe are seeking a highly experienced Quality Assurance Specialist to lead our CNC Machine shop in Santa Clara, CA. The ideal candidate will have a strong background in ISO certification and experience with mechanical inspection, First Articles, and in-process inspection.Responsibilities will include:Conducting mechanical inspections using standard...

  • Quality Assurance Specialist

    1 month ago

    Santa Clara, California, United States Summit Interconnect Full time

    Summit Interconnect is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for developing, implementing, and improving quality-related processes and procedures. You will study product flow, manufacturing methods, and apply quality principles to improve product consistency and conformance to...

  • Quality Assurance Director

    1 month ago

    Santa Clara, California, United States Fabrinet West Full time

    Quality Manager Job DescriptionAt Fabrinet West, we are seeking a highly skilled and experienced Quality Manager to lead our quality assurance efforts. This is a critical role that requires a strong leader with a passion for quality and a proven track record of improving processes and driving results.Key Responsibilities:Develop and implement quality...

  • Quality Assurance Manager

    3 weeks ago

    Santa Clara, California, United States Simco Electronics Full time

    Job OverviewThe Quality Manager will be responsible for maintaining and updating critical quality documentation, including laboratory accreditation, quality management systems, internal audits, and standards readiness. This role will also involve supporting and driving quality excellence across all laboratories.Key ResponsibilitiesLaboratory...

  • Software Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States SPECTRAFORCE Full time

    Job Title: Software Quality Assurance EngineerJob Summary: We are seeking a skilled Software Quality Assurance Engineer to join our team at SPECTRAFORCE. As a Software Quality Assurance Engineer, you will be responsible for ensuring the quality of our software products by designing and implementing effective test solutions.Key Responsibilities:Develop and...

  • Senior Quality Assurance Engineer

    1 month ago

    Santa Clara, California, United States Telenav Full time

    About the RoleWe are seeking a highly motivated Senior Quality Assurance Engineer to join our growing Auto team at Telenav. As a key member of our team, you will be responsible for ensuring the quality and reliability of our connected car and location-based platform services.Key Responsibilities:Review product requirements, user experience specifications,...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States Diamondpick Full time

    Quality Assurance Engineer RoleAt Diamondpick, we are seeking a skilled Quality Assurance Engineer to join our team. The ideal candidate will have a strong background in quality assurance and Java programming with experience in Selenium, JUnit, and TestNG. Additionally, fluency in scripting with JavaScript and experience with Eclipse, Jenkins, Maven, and Git...

Clinical Quality Assurance Manager

1 month ago

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

Shockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. We are seeking a highly skilled Clinical Quality Assurance Manager to join our team.

Job Summary:

The Clinical Quality Assurance Manager will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process. This role will support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed.

Key Responsibilities:
  • Act as a Clinical Quality Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices
  • Develop audit management plans and audit strategy for ongoing clinical trials
  • Prioritize audit strategies for GCP programs
  • Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines
  • Participate or lead in the development of departmental standard operating procedures, work instructions, forms, and templates
  • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
  • Conduct training for staff (GCP, Inspection Readiness training, etc.)
  • Prepare and support regulatory inspections
  • Write and review/revise Standard Operating Procedure (SOPs)
  • Responsible for initial and ongoing audit of clinical vendors such as CRO, imaging core lab, central laboratory and other vendors as needed
  • Identifies and escalates site, vendor and study related issues to management, as appropriate
  • Responsible to recruit, train, and mentor Clinical Quality resources
Requirements:
  • Bachelor's degree required. BS degree in scientific field of study is highly preferred but not required.
  • 10 years' experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred
  • 5+ years of experience in Quality in a related industry
  • 2+ years of people management or relevant experience
  • Experience conducting audits of vendors and investigative sites
  • Experience hosting and interacting with regulatory authority inspectors
  • Experience preparing and supporting clinical study sites undergoing regulatory authority inspections
  • Experience authoring and revising SOPs and procedures
  • Thorough knowledge and application of Good Clinical Practice (GCP) i.e. FDA, ISO, MDR
  • Knowledge and experience in supporting device pre- and/or post-market clinical studies
  • Medical Device experience is preferred
  • Ability to travel up to 30%-40% of time domestically and internationally
  • Excellent written and verbal communication skills
  • Basic understanding of peripheral and coronary artery disease and therapies preferred
  • ACRP or SOCRA certification preferred
  • Ability to work in a fast-paced environment while managing multiple priorities across multiple projects
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements
  • High attention to detail and accuracy
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

Shockwave Medical is an EEO Employer