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Quality Engineer III

The Quality Engineer III (QE III) will be an integral member of the BiVACOR quality team in supporting the quality related activities associated with the manufacture, test and distribution of the Total Artificial Heart (TAH) system. The QE III will also work with BiVACOR senior management to implement and supports maintenance of quality management system in accordance with ISO 13485 and 21 CFR 820, 803, and 806.

The QE III will assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices. The QE III will work with internal engineering staff from mechanical, electrical and software engineering backgrounds to support manufacturing process development and maintenance, The QE III 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 QA activities are sufficiently undertaken to support product development. QE III will identify and record potential problems relating to the product, process and Quality System. QE III will initiate, recommend or provide solutions through designated channels. QE III will then record and/or report all instances of customer feedback on product. QE III will finally verify the implementation of solutions.

BiVACOR is looking for motivated team members, who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility, strong organizational, time management, and technical skills. Analytical and problem-solving skills with the ability to multitask in a deadline driven environment, while working with minimal or no supervision is essential.

Responsibilities

o Ensure that the Quality System is compliant with 21 CFR 820, 803, 806 and ISO 13485.

o Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practice.

o Provide training and direction, as required, to junior team members with the organization.

oImplement quality methods throughout the organization, drive the use of quality tools in operation and product development, assist in resolving major product related issues

oCreate, 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).

oDefine, develop and implement processes and technical solutions to support product and process quality in accordance with quality principles which includes material control, acceptance sampling, and measurement systems.

• Assist with the develop and validation of test methods addressing the User Needs and Design Specifications.
• With the assistance of Quality and Regulatory personnel prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.

o Support preparation and maintenance of compliance to ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc.

o Coordinate and oversee sterilization validation activities.

o Coordinate and oversee maintenance of clean room environments (min. class 8).

o Review and approve Device History Records.

o Assist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes and components.

o Ensure systematic planning, and controlling of product and process quality in manufacturing

• Processes for planning product and service development
• Material control
• Acceptance activities
• Measurement systems

o Conduct inspection of components and subassemblies as required and document compliance to approved specifications and procedures.

o Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.

o Interact with external suppliers.

• Develop quality agreements and quality control plans in collaboration with suppliers.
• Lead supplier audits and participate in supplier visits.
• Develop responses to queries during and following the audit

o Quality System Support

• Complaint handling and investigation
• CAPA handling and investigation
• Guidance for completion of failure investigations

o Implement and support quality improvement models, corrective and preventive action, overcoming barriers to quality improvement.

• Participation in external audits – develop response to queries during and following the audit.

o Initiate action to prevent 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.

Requirements

• Bachelor’s degree or higher in Biomedical Engineering or similar, 8+ years work experience in medical device development or quality assurance.
• At least 5 years working at a class II or III medical device company. Ventricular Assist Device experience 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 experience through all phases (from product conception through commercialization) desirable.
• Proficient with Microsoft Office. Experience with project planning software packages, DAQ systems and interface with Matlab is highly desirable.
• Desirably holds certification/qualification from the American Society for Quality: CQE, CRE, CSQE, or CBA.

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 hr@bivacor.com.

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.