Quality Engineer II

The Quality Engineer II (QE II) will be an integral member of the BiVACOR quality team, supporting quality-related activities associated with the manufacture, testing, and distribution of the Total Artificial Heart (TAH) system. The QE II will also work with BiVACOR senior management to implement and support maintenance of the quality management system in accordance with ISO 13485 and 21 CFR 820, 803, and 806. The QE II will assist in the management of daily QA activities, including developing and performing validation & verification tests, as well as completing incoming, in-process, and final inspections of assemblies and devices. The QE II will collaborate with internal engineering staff from mechanical, electrical, and software engineering backgrounds to support the development and maintenance of manufacturing processes. The QE II may also assist with elements of design control, such as requirements, system hazards analysis, design, and process FMEAs. The QE will act as a liaison between the company and external suppliers to ensure that QA activities are sufficiently undertaken to support product development. They will identify and record potential problems relating to the product, process, and Quality System. QE II will initiate, recommend, or provide solutions through designated channels and will then record and/or report all instances of customer feedback on the product. QE II will finally verify the implementation of solutions. KEY RESPONSIBILITIES Quality System Management Ensure that the Quality System is compliant with 21 CFR 820, 803, and 806, as well as ISO 13485. Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques, and best practices. Support training and direction, as required, to junior team members within the organization. Implement quality methods throughout the organization, drive the use of quality tools in operation and product development, and assist in resolving major product-related issues. Create, edit, and maintain documentation related to design controls and quality system guidelines. Assist in the development of design input specifications and study designs. Write and review Standard Operating Procedures (SOPs) and Work Instructions (WIs). Support product and process quality in accordance with quality principles, which include material control, acceptance sampling, and measurement systems. Assist in the development and validation of test methods that address User Needs and Design Specifications. Risk Management and Compliance Support the preparation and maintenance of compliance with ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc. Coordinate and oversee sterilization validation activities. Coordinate and oversee maintenance of clean room environments (min. class 7). Review and approve Device History Records Assist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes and components Process Validation and Testing Support or lead validation activities, including IQ, OQ, and PQ for manufacturing processes Support or lead test method validation (TMV) and ensure accuracy in quality testing. Analyze quality data trends to drive process improvements. Assist in the development and validation of test methods that address User Needs and Design Specifications. Coordinate and oversee sterilization validation activities. Coordinate and oversee maintenance of clean room environments Review and approve Device History Records. Assist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes, and components. Support systematic planning and control of product and process quality in manufacturing. Conduct inspection of components and subassemblies as required and document compliance with approved specifications and procedures. Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods, and environmental conditions. Quality Conduct supplier audits and manage supplier corrective actions. Support production teams in resolving non-conformance issues. Interact with external suppliers. Develop quality agreements and quality control plans in collaboration with suppliers. Support Lean and Six Sigma methodologies to enhance efficiency. Drive initiatives to reduce defects, improve yield, and optimize processes. Support strategies for cost-effective quality improvements. Support quality improvement models, corrective and preventive action, and overcoming barriers to quality improvement. Participation in external audits – develop a response to queries during and following the audit. Initiate action to prevent the occurrence of non-conformities relating to the product, process, and quality system, and follow through the non-conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team regarding the progress and results of projects. Cross-Functional Collaboration Work closely with R&D, Regulatory Affairs, and Manufacturing teams. Provide technical guidance on quality-related issues. Train and mentor junior quality engineers. With the assistance of Quality and Regulatory personnel, prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies. REQUIRED SKILLS & QUALIFICATIONS Bachelor's degree or higher in Biomedical Engineering or similar, 8+ years of work experience in medical device development or quality assurance. At least 5 years of experience working at a class II medical device company. Experience with a Ventricular Assist Device would be highly valued. Experience with electrical/mechanical systems for medical devices in a regulated environment. Through understanding of design control requirements, verification, and validation for medical devices. Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics. Thorough understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards and requirements. Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up. Ability to develop and implement quality programs, including tracking, analyzing, reporting, and problem-solving. Thorough understanding of problem-solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements. Thorough knowledge of statistical analysis, reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting. Working knowledge of quality systems, risk management tools, and applicable standards, such as FMEA, QSR, ISO 14708, ISO 17025, ISO 14971, ISO 13485, 21 CFR Part 820, 803, 806. Working knowledge of gauges and precision inspection equipment/instruments. Experience in a Design Assurance role, with expertise spanning all phases (from product conception through commercialization), is desirable. Proficient with Microsoft Office. Experience with project planning software packages, DAQ systems, and interface with MATLAB is highly desirable. Physical Requirements While performing the duties of this job, the employee is regularly required to perform light material handling tasks involving lifting weights of up to 35 pounds for short durations. This position requires sitting for extended periods, up to and sometimes exceeding 8 hours a day. Duties will also involve keyboard data entry. SALARY: $90,2000 – $97,000 annually, based on experience BiVACOR

is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution. Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. 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. 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 hr@bivacor.com . Our Benefits and Perks

Health and Welfare

Medical Benefits – Numerous HMO and PPO options, several of which have monthly premiums fully employer funded. Dental/Vision, Short-term & Long-term Disability also available at low employee cost. Vacation and PTO

BiVACOR also has very generous vacation and PTO policies. Vacation policy for first year employees is 80 hours per year. Increasing yearly up to 136 hours upon 7th year of employment. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year. 401(k)

BiVACOR proudly offers both Non-Elective and Elective 401(k) plans. Our Non-Elective 401(k) is a 4% employer only contribution, made on your behalf each pay period and immediately vested upon 90-day qualification. Our Elective 401(k)-employer match is up to 6%. That means that for every dollar you contribute to your 401 (k), you will receive a matching dollar-for-dollar contribution in your account up to 6% of your pay. Incentives

Short-Term and Long-Term Incentives are also part of our current benefit package.

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