Document Control Specialist

Cutera Brisbane , CA 94005

Posted 1 week ago

Company Description

About Us: Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right person to help grow our business and reap the rewards of doing it! We hire the best people and provide them the best comp and benefits to help improve their lives. Read more at www.cutera.com

Job Description

Position Summary:

  • Responsible for the administration of the document and training management systems

  • 'Gatekeeper' for the Cutera document control system

  • Foster a strong 'right first time' compliance culture

  • Be solutions oriented and a business partner for QMS Enterprise software

Duties and Responsibilities:

  • Manage the development and maintenance of document control and learning management systems at Cutera

  • Administer Arena PLM system including maintenance of user accounts and configuration management

  • Work with functional management to develop and maintain employee training plans

  • Identify and evaluate systems for training that utilize current industry best practice to provide a user-friendly, cost-effective system that meet business and regulatory requirements

  • Perform user training on the document management system, electronic signature workflow and document control processes

  • Publish reports on employee training status and develop plans for improving completion

  • Manage the document change process for the submission, routing, review, approval, publishing and archiving of Cutera quality system documents

  • Ensure revision and change control is maintained, documents are entered correctly and follow Cutera, FDA quality system regulation, ISO 13485, EU MDR requirements

  • Manage master lists and files for product DHF, DMR and DHRs

  • Develop and manage plan to transition remaining legacy paper-based system into the Cutera electronic document management system (eDMS)

  • Develop templates; ensure only the approved document templates are used for creating, updating quality system documents

  • Withdraw obsolete and superseded documents from circulation and prevent use thereof

  • Provide timely documentation and assistance during audits and inspections

  • Provide reports to management on the performance of the document management process against agreed KPIs, as well as making recommendations to ensure continuing effectiveness

  • Other duties as assigned

Qualifications

  • Document control experience in a regulated industry required

  • Associate's/Bachelor's degree in technical or business management related field preferred

  • 5 to 7 years of related QA experience required

  • Experience with Arena Solutions PLM system would be an advantage

  • Ability to work with all levels of organization in a fast-paced environment

  • Strong written and verbal communication

  • High attention to detail

  • Proficiency in MS Windows Word, Excel and PowerPoint

Additional Information

All your information will be kept confidential according to EEO guidelines.

If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.

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