Doc Control Specialist
About The Position
SRI Healthcare, LLC, a Subsidiary of NOVO Health Services offers a healthcare service that provides a total and unique opportunity for hospitals to source their Sustainable Reusable Sterile Packs as well as other sustainable healthcare linens such as DermaTherapy®, Isolation Gowns, Sterilization Wrap, and cubicle/privacy curtains. SRI's products and services help Healthcare providers attain their sustainability goals, improve surgeon and staff satisfaction while ensuring continuity of supply. SRI operates three regional processing facilities located in Raleigh, NC, Chattanooga, TN, and Mason, OH. Our state-of-the-art, FDA-regulated service centers provide daily processing, assembly, and delivery of reusable products required for surgery. SRI is the only “one stop shop” service provider in U.S. currently serving all healthcare-related end markets with Sterilized Reusable Surgical Solutions. SRI Healthcare is seeking a highly skilled and experienced Document Control Specialist to join our team at the Mason, OH facility. Join a collaborative team that provides high-quality service to healthcare partners across the region. We are currently seeking a Document Control Specialist to administer SRI Healthcare's documentation, procedures and filings in accordance with all current FDA and International Regulatory requirements as well as other applicable regulatory agencies. Documentation includes Standard Operating Procedures, product specifications, product complaints, certifications, and other facility and corporate documentation and reporting responsibilities.
Responsibilities
- Administration of the document control system.
- Establish and report metrics, indicating regulatory and quality compliance.
- Examine documents to verify required compliance, completeness, and accuracy of data.
- Confer with document originator and approvers to resolve identified discrepancies and apply required document changes.
- Control document databases, and corresponding files.
- Generate communication documents to the appropriate personal on new and revised documents.
- Maintain Employee Training Records.
- Maintain Organizational Charts
- Assist with Internal and External Audits.
- Evaluate data and write reports to validate or indicate deviations from existing standards and processes.
- Perform clerical duties to generate documents as necessary.
- Maintain a computer database of all documentation that will allow secure document retention and timely retrieval.
- Support continuous improvement activities in terms of process and system improvement.
- Support the implementation, maintenance and improvement of quality systems based on information in SRI Healthcare strategic planning, audits, changes and priorities within the organization.
- Identify the opportunities for development and improvement in business operational processes in line with corporate goals, strengths and limitation.
- Prepare graphs, charts and presentations using MS programs and other software packages to support the QA/RA Leadership team.
- Assist/Support with the preparation of protocols and final report for the Engineering team, including but not limited to, validations, Business Development Projects, 510(k) filings, etc.
- Contribute to team effort by accomplishing related inquires as needed.
- Other duties and responsibilities as may be assigned by Quality Management
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
