Santa Clara Categories:
Document Change Control Specialist (Req #308) OptiMedica
THIS JOB HAS EXPIRED
We are looking for a Document Change Control Specialist (Req #308) to join our team of dedicated medical device professionals. This person is responsible for managing the change control (ECO) process and ensuring it is in compliance with corporate quality and regulatory requirements. Reporting directly to the Director of QA/RA this individual will oversee the document change control process, maintain the in-house regulatory documentation, training personnel in the Product Lifecycle Management (PLM) system, and insure the documentation process meets regulatory requirements.Interested in applying or learning more, please contact careers@optimedica.com ? please reference the requisition number and the job title.
Job Functions:
Manage the Product Lifecycle Management (PLM) System by maintaining system controls and training new employees in the use of it. Assist in the day-to-day support of the PLM System
Review, process and educate employees in the Engineering Change Order (ECO) and Deviation (DEV) processes
Receive, review, and analyze ECO and Deviation Packages and ensure they are complete and compliant with current requirements for submission
Maintain Design History Files, Device Master Records, and Device/Lot History Records
Audit ECOs and Deviations for accuracy and completeness
Develop training and records for the all procedures and communicate to employees when training and re-training is necessary
Ensure document control processes are compliant with FDA (QSR), ISO, and company quality requirements
Assist with the creation of new documents and new Bills of Material as necessary
Review and revise documents pertaining to document control, quality assurance, and other areas, as needed
Assist with the modification of existing documents and Bills of Materials as necessary
Maintenance of hard copy files, electronic documents, controlled document binders, and notify affected parties of changes to them.
Assist employees in identifying documents to be written and/or revised for new product and process introductions
Oversee the record retention activities relating to product related documentation. Scan hard copy quality records as needed
Assist regulatory affairs with the coordination, preparation and compilation of document packages for regulatory submissions
Requirements/Skills:
3 plus years in an Engineering Change (ECO) Analyst role
5 plus years experience in a documentation control role
1 or more years of recent experience in the medical device or bio-tech industry
Experienced user of Microsoft Word, Excel, PowerPoint, Visio, Adobe Acrobat
Knowledge of electronic PLM systems setup/administration including defining requirements, implementation and maintenance of systems desired
Strong organizational skills (e.g. time management, record management, paperwork)
Able to multi-task and meet deadlines
Communicate effectively verbally and in writing
Able to assist and teach others about documents and document maintenance
Self starter with the ability to work with minimal supervision
Education:
A.S. / B.S. degree (or equivalent knowledge and skills)
Preferred Qualifications:
Knowledge of various Document Control Systems a plus
Currently using Arena/BOM Control Software is a plus
| Location: | 3130 Coronado Drive Santa Clara, CA 95054 United States |
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THIS JOB HAS EXPIRED
OptiMedica
Investors: Alloy Ventures, Kleiner Perkins Caufield & ByersAll Jobs: at OptiMedica
| Web Site: | www.optimedica.com |
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| Headquarters: | 3130 Coronado Drive Santa Clara, CA 95054 United States |
| Industry: | Medical Devices and Equipment |
