Document Control Specialist
QA/RA | Agoura Hills, CA | Full Time
The Document Control Specialist maintains and controls the issuance and organization of all engineering technical documentation.
- Responsible for control, filing, retrieval, and maintenance of master and reference documents. Responsible for electronic and hard-copy archival system for controlled documents.
- Manage document changes and approvals
- Receive, review, process control, and track, DMRs, LHRs, Product Release Approvals, and other documents, per the relevant procedures
- Complete text and drawing updates for various procedures, policies, assembly instructions, and other controlled documents
- Control, log, and assign part numbers and routing additions, deletions, and changes
- Identify and implement improvements to the Controlled Document system
- Maintain information from Operations, Design Control, Clinical Research, and Marketing activities, such as MSDS, Design History File, and competitive benchmarks
- Perform audits regarding controlled documents, and other related quality systems as needed
- Train personnel regarding document format, content, use, and control, and the Document Control System
- Conduct company-wide training for new documents and revisions, and the implementation of central archive for training
- Organize standards and maintain current version of standards
- Support regulatory filings
- Other duties as assigned
- Associates Degree or equivalent work experience
- At least 2 years related experience and/or training in medical device organizations
- Ability to effectively and expeditiously create, modify, and review various documents and quality records
- Demonstrated ability to work well with individuals and teams
- Strong record-keeping skills, multi-tasking and orientation to detail
- Good organization, interpersonal, and time management skills
- Ability to understand BOMs, routing, part numbering systems
- Knowledge of relevant cGMP, ISO 13485, 21 CFR 820 requirements for document control and quality records
- Ability to use programs such as Excel, Word, Adobe, Illustrator, PowerPoint and other programs, in windows platform
- Experience with both “paper” and “paperless document systems” is and/or experience with transition to a paperless system is a strong plus
- Proofreading, technical editing, and technical writing skills a plus.
About Caldera Medical:
Caldera Medical is a growth stage medical device company focused on designing, manufacturing, and marketing products into the Gynecology, Urology and Urogynecology surgical markets. We are searching for highly motivated, dynamic and results oriented individuals to join us in improving the quality of the patients we serve.
- A Culture of family and team…not a corporate goliath where you’re just another number
- All employees get a seat at the table and have influence with management
Women’s Health Initiative - Giving back to those who can’t afford treatment
- Goal to treat 1 million women suffering from incontinence by 2025!
- Competitive Compensation
- Basic Life and AD&D
- Unlimited Vacation
- 6 Weeks Paid Maternity Leave
- Kitchen stocked with free snacks and drinks
- Being surrounded by talented and engaged employees
- Medical / Dental Benefits – 75% paid for employee and family members
- 401(k) with 4% matching contributions
Learn more about us on Glassdoor - https://www.glassdoor.com/Reviews/Caldera-Medical-Reviews-E356568.htm
Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.