Join Our Team

We are always looking for talented individuals with passion for driving innovation and helping patients.

View our latest job openings below and apply today. Don’t see an opportunity that matches your expertise? Contact us at careers@cath.works for more information.

< BACK

Commercial Operations & Quality Systems Manager – USA

Commercial Operations & Quality Systems Manager, CathWorks Inc

 

Join us to become a driving force in the launch and commercialization of the groundbreaking, diagnostic & interventional cardiology technology, FFRangio™. The CathWorks FFRangio™ System provides a Fractional Flow Reserve (FFR) analysis using a non-invasive Artificial Intelligence (AI) software instead of an invasive wire, revolutionizing the diagnostic value of an angiogram. As an integral part of the US commercial launch, incumbent will partner with Commercial and Operations senior leadership team to execute strategic priorities for the company. Operations & Quality Systems Manager, is responsible for managing commercial function interdependencies and key sales business operations processes and activities including the management of sales team and hospital service requests.

Operations & Quality Systems Manager is part of the commercial team and report to the Director of Global Marketing. Operations & Quality Systems Manager will closely collaborate with multiple departments including Sales, Marketing, Operations, Quality, Regulatory, Customer Service and Finance.

Job Responsibilities:

  • Execution of the company-wide quality system.
  • Act as the point-of-contact to manage 3rd party logistics and operations vendors, including development of processes and management of the execution.
  • Act as the single point-of-contact for sales team and hospital service requests for new delivery, installation and service call. In this capacity the incumbent will become the facilitator of the planning and execution of delivery, installation and service work orders. This will require close collaboration with multiple internal and external stakeholders including hospital support staff, sales team, internal functions and 3rd party vendors.
  • Act as the single point-of-contact to receive, monitor and route all sales quality complaints – Handle all applicable communications and administrative follow-up. This will require close collaboration with the sales team, commercial leadership team, quality and regulatory functions.
  • The successful incumbent will develop and implement business operations planning tools and processes that maximize strategy plan execution.
  • The primary focus of the role is to lead the development, delivery, administration, and continuous enhancement of key strategic resources, services, and processes for the commercial organization that allow CathWorks to operate in an effective, efficient and compliant manner.
  • Lead commercial operations activities
  • Develop and maintain efficient reference documentation, including SOPs, process flow maps, audit-ready archives, and training resources
  • Ensure all programs, processes and resources within Commercial Operations remain compliant with all applicable laws and regulations
  • Proactively identify opportunities for new services, and continuously enhance the efficiency / effectiveness of all service offerings
  • Work with key business partners (internal and external) to set strategy and roadmap to accomplish company’s strategic goals
  • Responsible for leading, facilitating and directing the activities of 3rd party logistics vendors.
  • Fully accountable for performance metrics of safety, quality, delivery and cost.
  • Ensures the timely distribution and receipt of product while meeting the distribution center standards of budget, policies, procedures and quality
  • Promotes the process of continuous quality improvement and coordinates solutions for technical and personnel issues. Troubleshoots complex problems. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Drive improvement projects and lead team members to ensure compliance with domestic and international regulations and standards
  • Lead direct reports and manage systems and processes to ensure effective reporting, trending, and communication
  • Demonstrate effective leadership skills and work within a team environment, striving to meet or exceed customer expectations, and committing to continuous improvements in quality
  • Review, monitor, and approve programs and documentation, as assigned, to ensure compliance with relevant standards, regulations, and guidance documents
  • Coordinate, liaise, and participate with internal teams to provide guidance on regulatory and/or quality systems compliance
  • Learn and understand relevant domestic and international standards and regulations in order to monitor and ensure conformance
  • Manage and participate in projects to maintain and improve the Quality System in accordance with national and international standards and regulations
  • Participate in and/or facilitate internal and external audits
  • Provide guidance in quality data trending and analysis; evaluate and present report of analysis

 

Requirements:   

  • A bachelor or equivalent 4-year degree in Business, Operations, Engineering or related field or equivalent work experience is required. Minimum of 5 years of experience, including a minimum of three (3) years of experience in a combination of Operations, Engineering, Quality Systems/Regulatory Affairs, and/or other relevant subjects in the medical device industry or equivalent.
  • Previous experience in business operations, commercial operations, supply chain or IT.
  • Ability to coordinate/participate/manage in numerous tasks/projects in a fast-paced environment in an organized manner while meeting deadlines.
  • Customer facing skill-set that includes being driven and self-motivated, holding strong communication & interpersonal skills, being organized, and have proven record of closing and delivering. Speaking Hebrew is a plus.
  • Strong analytical skill-set to problem solve, plan and execute business operation challenges.
  • The ability to potentially travel abroad for training purposes.
  • Excellent customer service skills, interfacing with multiple constituencies including hospital support staff and sales in order to effectively build relationships with external customers and internal team members.
  • Entrepreneurial spirit with a competitive drive, and a work ethic conducive to success.
  • Comfortable with a fast pace environment and wearing multiple hats as needed.
  • Follow-through on tasks, collaborative across different functions and extend your role beyond the expressed Clinical Specialist requirements.
  • Ability to provide technical input related to regulatory and/or quality systems to project teams
  • Ability to analyze, using statistical techniques when applicable, and present data regarding products, projects, and the Quality Management System
  • Training in Quality Systems including QSR/GMPs, and relevant ISO Standards
  • Demonstrated ability to successfully lead and strengthen teams and projects

 

About CathWorks:

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize PCI therapy decisions and elevate coronary angiography from visual assessment to an objective FFRangio based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers.  The company’s focus is specifically on bringing the CathWorks FFRangio System to market to provide quick, precise, and objective intraprocedural FFRangio guidance that is practical for every case.

CathWorks, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.

Unless stated otherwise, all positions posted for CathWorks are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

  • Accepted file types: pdf, doc, docx, txt.
  • Accepted file types: pdf, doc, docx, txt.
  • *Required fields
    Accepted file types: pdf, doc, docx, txt
  • This field is for validation purposes and should be left unchanged.

For USA only: CathWorks, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.

Unless stated otherwise, all positions posted for CathWorks are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.