- Maintain systems to manage Quality Management System (QMS) documentation (ie. Procedures, Forms, Labeling, Complaint, Supplier Files, CAPA)
- Manage Excel based logs (Complaints, ECO, & Periodic Review)
- Ensure data integrity and security of all databases and physical records containing data relevant to product quality and/or Quality Systems processes
- Coordinate and oversee change control activities; analyze document changes for completeness and alignment with change history. Ensure the correct and timely implementation of document control requests. Verify own work; check format and compliance with document templates.
- Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are released
- Assist with complaint management activities; coordinate complaint investigation with Operations and Engineering
- Manage and ensure compliance of periodic reviews of controlled documents
- Knowledgeable of and follows the applicable provisions of the QA department's standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMPs). Employee remains knowledgeable on an ongoing and timely basis as changes in the SOPs and cGMPs occur.
- Maintain web based signing platform; onboarding, in-process, and audit reporting
- Scans, files, and maintains all quality records per the record retention policy
- Maintain confidentiality around sensitive documentation
- Conducting regular reviews and document audits
- Provide support during internal and external audits
- Support RAQA Team with projects
- Other responsibilities assigned by supervisor
- Strong organizational and analytical skills, with superior attention to detail
- Demonstrated ability to multitask and prioritize activities to completion
- Solution-oriented team player that has a customer service approach with internal and external stakeholders
- Excellent English written and verbal communication
- Knowledge and understanding of standards and regulations: 21 CFR 820, ISO 13485, MDSAP, EU MDR
- Advanced knowledge and demonstrated experience with MS Office and Adobe products (e.g., Word, PowerPoint, Excel, Visio, and Acrobat Suite).
- Knowledge and use of electronic quality management systems (ie. Sharepoint, TrackWise, Qualio, Green Light Guru, Grand Avenue)
- Direct experience with complaint handing and reporting
- Ability to foster Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Abide by team decisions
- Highschool diploma or equivalent; college degree preferred
- Minimum 2 years' experience in document management, archive management, or records management
- Minimum 2 years' experience with medical device complaint and vigilance requirements
- On Site
- Business casual attire.
- Occasionally requires attending corporate functions
- Ability to lift up to 25lbs.
- Medical Device
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Document Control and Records Administrator - Sugar Land, United States - TeDan Surgical Innovations
2 weeks ago
Description
Company description:
TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries.
TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.
Job Summary:
The Document Control and Records Administrator is a detailed oriented quality focused individual who ensures documentation and record keeping processes conform to ISO 13485 and applicable FDA requirements as well as TSI approved procedures and output documents are accurate. This position is responsible for administering the collection of, authorization, publication, storage, retrieval, and retention documents per established procedures to ensure control and availability of documentation to internal and external stakeholders. This person will interact with all TSI employees to ensure documentation practices are adhered to and fully implemented.
Duties/Essential Job Functions:
Experience/Skills:
Required Education/Licensing/Certification:
Physical Requirements:
Industry
Employment Type
Full-time
