Quality Engineering & Assurance

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.

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.

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.

Support product and process quality in accordance with quality principles, which include material control, acceptance sampling, and measurement systems.

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 maintenance of clean room environments (min. 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 test method validation (TMV) and ensure accuracy in quality testing.

Analyze quality data trends to drive process improvements.

Coordinate and oversee maintenance of clean room environments

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

Develop quality agreements and quality control plans in collaboration with suppliers.

Support Lean and Six Sigma methodologies to enhance efficiency.

Support strategies for cost-effective quality improvements.

Support quality improvement models, corrective and preventive action, and overcoming barriers to quality improvement.

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.

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.

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 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.

Proficient with Microsoft Office. Experience with project planning software packages, DAQ systems, and interface with MATLAB is highly desirable.

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. Duties will also involve keyboard data entry.

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. 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. 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. 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 View email address on click.appcast.io 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. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year.

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.

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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