Document Control Specialist

Confluent Medical Technologies; Austin (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

A rapidly growing medical device company seeks a passionate Documentation Control Specialist to join their innovative team. This role is vital for maintaining quality systems related to document control, ensuring compliance with ISO and FDA regulations, and supporting audits. You'll have the opportunity to directly impact life-saving solutions while working in a collaborative environment that values growth and leadership. If you're looking to make a difference in the medical industry and thrive in a high-impact role, this is the perfect opportunity for you.

Qualifications

• Bachelor’s degree or equivalent experience required.
• Knowledge of ISO and FDA regulations is essential.

Responsibilities

• Maintain and control quality systems related to document control.
• Support internal and external audits and maintain logs for documents.

Skills

Document Control

Quality Systems Management

Regulatory Compliance (ISO, FDA)

Analytical Skills

Report Writing

Presentation Skills

Education

Bachelor’s degree

Tools

BWOS

ERP System

Job description

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our environment reflects a culture of growth, leadership, and innovation in which our employees can directly impact the world by doing work that truly matters.

We are looking for a Documentation Control Specialist reporting to (insert hiring manager job title) to join our talented team in (Insert location).

Summary:

1. Maintain and control quality systems related to document control.
2. Maintain the Device Master Record and Device History Record for all products.
3. Review and release documents to central distribution.
4. Notify required individuals about documents released.
5. Maintain various databases with information of all released documents, keep Document Master List up to date.
6. Maintain logs related to the approving and release of documents.
7. Maintain BWOS and ERP System as it pertains to Doc Control and QSR ISO requirements.
8. Coordinate and control that product and product process changes documented through the product/process change system are validated according to the established requirements per Design and Change Control systems.
9. Hold CCB meeting to ensure timely closures of ECRs.
10. Maintain Design History Files per the PPCN process.
11. When product change requires, notify parties affecting the system of the dose map verification requirement.
12. Maintain Log related to issuance and closure of Protocols/Reports.
13. Maintain External Document Library.
14. Support appropriate parties during internal and external customer and regulatory audits.

Qualifications/Requirements:

1. Bachelor’s degree (B.A.) from four-year College or university; or equivalent combination of education and experience.
2. Knowledge of International Standards (ISO) and FDA Regulations for Medical Industry.
3. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations.
4. Ability to write reports, business correspondence, and procedure manuals.
5. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.