Director of Quality Assurance

DIRECTOR OF QUALITY ASSURANCE

The Director of Quality Assurance is responsible for the strategic development and execution of BiVACOR’s quality assurance and is accountable for the execution and administration of the quality assurance and compliance strategy, Quality Management Systems (QMS) and policies to assure compliance to FDA and international regulations across products and all regulatory audit and inspection activities.

The Director Of Quality Will

• lead a dedicated team responsible for the quality oversight for the entire organization through the use of the quality management system and associated processes;
• ensure that the corporate policies and processes are appropriate for each phase of development, and comply with corresponding regulations; and
• oversee the development, implementation and management of a quality management system in accordance with ISO 13485, 21 CFR 820, EU MDR, and AIMD Directive 90/385/EEC.
  
  

The Director of Quality is the most senior quality role within BiVACOR and is a strategic part of the BiVACOR’s senior leadership team.

Responsibilities

• Oversee all aspects of planning, developing, and executing quality assurance policies, programs, and initiatives of the BiVACOR Total Artificial Heart (TAH)
• Oversee the development, implementation and management of a quality management system (QMS) in accordance with ISO 13485, 21 CFR 820, EU MDR, and AIMD Directive 90/385/EEC.
• Establish audit and surveillance protocols to monitor the entire production process.
• Develop training programs, standards, tools, and methods to foster a culture of quality within the company.
• Provide regulatory guidance to R&D teams for assessing device and manufacturing changes.
• Develop regulatory strategies and the writing, compiling and submission of regulatory documents to the FDA and other Regulatory Agencies.
• Define, implement and manage the processes for quality supplier qualification of vendors.
• Establish and chair Quality Management Review to ensure visibility and governance for the performance and improvement of the QMS.
• Participate in development planning and resource management activities as required.
• Assist in writing SOWs, NDAs and other supplier related contracts.
• Manage BiVACOR quality engineers and quality assurance staff and contractors.
• Establish and maintain a set of clearly documented quality systems, standards and procedures defining the requirements of products and to advise on the application of these requirements.
• Direct and oversee the execution of the QMS specifically for Clinical and medical devices.
• Execution and outcomes of quality audits, including internal systems and external vendors.
• Accountable for quality interfaces end-to-end in the development process from early phase research to manufacture and commercial launch.
• Interface with other disciplines including Clinical, Regulatory, Engineering, Project Management, and Manufacturing to ensure effective QMS transition between R&D and commercial processes.
• Define, implement and manage the processes for Quality supplier qualification of vendors.
• Ensure Quality Management Reviews occur within stipulated timelines and issues are escalated to the senior engineering team.
• Oversee and participate in the writing, review, editing and compilation of regulatory submissions and quality documentation. Documents may include FDA submissions and IDEs for EFS, HDEs and PMAs, Supplements/ Amendments/Annual Reports, Change Notifications, Technical Files/Design Dossiers and responses to regulatory agencies’ questions and other correspondence
• Maintain current and in-depth knowledge of FDA and Worldwide Regulatory Authority programs, policies and guidelines with the ability to work effectively across different cultures and markets.
• Assure that all submission documentation, record keeping, and reporting meet inspection standards as established by regulatory agencies worldwide.
  
  

Requirements

• Bachelor’s Degree in a Life Science or Mechanical, Electrical or Biomedical Engineering.
• Minimum 15 years of relevant experience in a QA leadership position in the medical industry, preferably in the implantable medical device development field.
• 10+ years of experience with a Class III medical device manufacturer.
• Proven ability to deal effectively with regulatory agencies and notified bodies with coordination of product submissions and approvals.
• Extensive knowledge and in-depth experience of implementation of quality management system.
• A hands-on leader with managerial experience who leads by example, inspires, and empowers team members.
  
  

BiVACOR offers a competitive compensation package to include 401k with above-average employer contributions, generous amount of time off, a choice of rich healthcare plans and an array of other benefits.

About The Company

BiVACOR is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human Early Feasibility Study (EFS). Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions. Our highly driven and performing team has complementary science and business minds to focus on “Replacing Hearts and Restoring Lives”.

Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us. To learn more about us go to www.bivacor.com.

BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email [email protected].

BiVACOR does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by BiVACOR, implied or otherwise.