Some opportunities happen only once in a lifetime – like choosing a position where you have the chance to change lives. BiVACOR is a preclinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. We're a team of hard-working, high performing specialists looking to grow our Huntington Beach, CA location and hire a Quality Engineer I. Come join the team where technical and business minds collaborate to focus on Replacing Hearts and Restoring Lives.

The Quality Engineer (QE) will be an integral member of the BiVACOR engineering team to support all quality assurance activities for manufacture and test of the Total Artificial Heart (TAH) system. The QE will work with the team to assist in implementing a QM system in accordance with ISO 13485 and 21 CFR 820.

The QE will work on daily Quality Assurance (QA) ad Quality Certification (QC) activities including:

• supporting creation and review of work instructions, inspection instructions, test protocols, and process Design Change Orders (DCO);

• provide purchasing, inventory control and quality support to maintain company operations;

• conducting inspection activities both internal at BiVACOR and its suppliers;

• working with the internal engineering staff to the support manufacturing and testing including documentation and process improvements;

• supporting execution of test procedures; and

• support the company and external vendors/suppliers to ensure QA activities are sufficiently undertaken to support product development and conduct supplier qualification.

This role requires the ability to work with minimal supervision and will report to the Quality Engineering Manager.

Located in Huntington Beach (CA), BiVACOR is looking for motivated and flexible team members, who are keen to contribute to this active and dynamic project. Strong organizational, time management, and technical skills paired with an analytical and problem-solving thinking in a deadline driven environment is needed.

This role requires creativity and flexibility to find the best solutions in a multidiscipline and dynamic research and development environment.

RESPONSIBILITIES

• Develop and review travelers, work instructions, test procedures and reports for the manufacture and inspection of TAH system components.

• Perform incoming receiving inspection.

• Review incoming products from vendors/suppliers and identify flaws and issues with quality.

• Conduct in process inspection as required.

• Conduct and support inspection of components, including kitting and inventory control.

• Support and conduct root cause and corrective action to improve manufacturing and test processes.

• Provide inventory control of components and products and maintain an inventory data base.

• Interact with external suppliers/vendors including perform supplier audits and participate in supplier visits.

• Maintain detailed reports related to supplier quality – report on supplier quality status and drive changes in vendor/supplier processes.

• Support engineers to resolve supplier quality issues that may arise.

• Update company systems with purchase order and purchase receipt data.

• Coordinate with engineers to ensure incoming/receipt storage and organization requirements are met.

• Participate in problem-solving efforts to resolve rejections, supplier corrective actions and receiving issues.

• Create, edit, and maintain documentation related to design controls and quality system guidelines including Standard Operating Procedures (SOPs) and Design Change Orders (DCO).

Requirements

• Bachelor’s degree or higher in Engineering, Science or technical field

• 1-3 years’ professional quality engineering working experience in medical class II or III device development.

• Working knowledge of quality systems, risk management tools and applicable standards, such as 21 CFR Part 820 and ISOs 14708, 17025, 14971, 13485.

• Working knowledge of gauges and precision inspection equipment/instruments.

• Previous experience in a Quality Assurance role with experience through all phases (from product conception through commercialization).

• ASQ Quality Inspection Certificate or equivalent desired

• Proficient with Microsoft Office.

Occasional travel may be required, up to 2 weeks per year.

Compensation Range: $78,083 - $85,654 + bonus + benefits

The above represents the expected salary range for this job requisition. Ultimately, in determining pay, we’ll consider job location, experience, and other job-related factors.

BiVACOR offers a competitive compensation package to include a 401k with match, generous time off, a choice of healthcare plans and an array of other benefits. In addition, this position will be eligible for short-term and long-term incentive programs.

About the Company

BiVACOR® is a preclinical 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 Houston, TX with an engineering office in Huntington Beach, CA, and 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 Surgical 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 recognising 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.