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 Document Control Specialist (DCS) with Medical Device Experience. Come join the team where technical and business minds collaborate to focus on Replacing Hearts and Restoring Lives.

The Document Control Specialist will be an integral member of the BiVACOR engineering team to support all document control activities for the design and manufacture of the Total Artificial Heart (TAH) system. The (DCS) will work with the team to assist in updating and maintaining Documentation Controls in accordance with ISO 13485 and 21 CFR 820.

The Document Control Specialist will work on daily Quality Assurance (QA) activities including:

• Processing Document Change Orders (DCO)

• Collaborating and offering guidance and support for DCO initiators

• Coordinate the review and approval of documentation

• Maintain Document Change Order Log and Document Master Logs

• Monitor Document Control Metrics

• Assist with Quality Records

• Maintain Records in the document control system in a state of audit readiness

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

Responsibilities

• Process incoming document change orders to support product development, manufacturing and quality system updates and improvements.

• Collaborate with subject matter experts for content and change process support.

• Initiate change orders, as appropriate, incorporating the required information to support the type of change impacted within the recommended timelines.

• Train personnel on changes and improvements to the document change order process, procedures, forms, and approvals.

• Assist in the improvement of the document control process and procedures.

• Follow and sustain good documentation practices.

• Scan and upload documents and records.

• Update other logs, as necessary.

• Training record management.

• Assist with Device History Record reviews.

Requirements

• At least 3 years of Documentation Control experience in the medical device field.

• Working knowledge of quality systems, and applicable standards, such as 21 CFR Part 820 and ISO 13485.

• Knowledge of GDP in the medical field.

• Previous experience in a Document Control role in a GMP regulated environment.

• Proficient with Microsoft Office, Adobe Acrobat and Adobe Illustrator.

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

Compensation Range: $25 – 35/hour + 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 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.