Quality Assurance Engineer jobs in Irvine, CA

CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with comprehensive physiologic information, enabling them to make better treatment decisions for their patients with coronary artery disease. 

Recently, CathWorks entered into a strategic partnership with Medtronic to market and sell the FFRangio System globally. Medtronic is the global leader in medical technology and has more than 90,000 employees worldwide in more than 150 countries. The partnership with Medtronic will expand CathWorks’ footprint globally, enabling more patients to benefit from its revolutionary technology that is poised to disrupt the current coronary physiology market. 

As a Quality Assurance (QA) Engineer at CathWorks, you will play a pivotal role in supporting and ensuring the quality and compliance of our products and processes. Your responsibilities will encompass various aspects of quality assurance, including documentation management, training oversight, and process maintenance. This role is crucial for maintaining the high standards of quality that are integral to CathWorks' mission of improving the lives of patients through innovative healthcare solutions.

Job Description:

Quality System Management:

• Maintain and enhance quality system activities to align with QA department goals.
• Report on system performance, initiating and leading quality improvement actions.
• Assist in writing and updating procedures for regulatory compliance, including ISO13485: 2016 and USA 21 CFR§820.

Quality Process Oversight:

• Participate in the maintenance and improvement of quality processes like MRBs, CAPA, failure investigations, and customer complaint handling.
• Manage the US complaint intake process, working with field associates and investigation teams.
• Summarize complaint investigation findings for customer communication.
• Initiate, manage, and create action plans for CAPAs and MRBs, collaborating with the product team for MRB dispositions.
• Analyze key data for trends in CAPA/MRB and complaints.

Document and Training Management:

• Provide US support for LMS/DMS, including document revisions and approvals, ensuring proper management of controlled documents on platforms like Showpad and SharePoint.
• Oversee training aspects using our QMS (Simploud): manage overdue training items, create new-hire training plans, lead annual company-wide and individual onboarding quality training, and set the annual US training plan.

Vendor and Logistics Coordination:

• Manage documentation control and oversee the approved supplier list.
• Act as the primary contact for managing third-party logistics and operations vendors, including sales team coordination and handling sales quality complaints.
• Lead and manage third-party logistics vendors, ensuring adherence to safety, quality, delivery, and cost metrics. Perform on site audits according to the QA audit plan.
• Maintain the device DHR in the electronic system, review and approve installation files and service reports

Compliance and Continuous Improvement:

• Ensure that all Commercial Operations' programs and processes remain compliant with applicable laws and regulations.
• Collaborate cross-functionally with internal and external partners to develop strategies, meet the company's strategic objectives, and uphold quality standards while improving operational efficiency.
• Support and contribute to both internal and external audits.
• Monitor conformance to both domestic and international standards and regulations.
• Engage in projects aimed at maintaining and improving the Quality System in accordance with national and international standards.

Required Qualifications/Skills:

• Bachelor’s degree in a related discipline or equivalent work experience.
• 3-5 years experience in Quality Assurance or a related field, with knowledge of quality systems.
• Excellent written, verbal, and presentation skills with a strict attention to detail.
• Strong organizational skills, time management skills, and ability to manage competing priorities in a fast-paced environment.
• Ability to work with teams across our organization and adapt to working with team members in different time zones and locations.
• Proficiency in using quality management systems and software.