What are the responsibilities and job description for the Document Specialist position at INSPYR Solutions?
Summary
Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.
INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities
The Document Control Analyst will support product programs by managing Standard Operating Procedures (SOPs), Work Instructions, Forms, and Records throughout the product lifecycle—from concept to obsolescence. This role requires experience working in regulated environments (e.g., ISO 13485) and the ability to operate with minimal supervision. The ideal candidate is flexible, detail-oriented, hands-on, and able to manage competing demands effectively.
Responsibilities- Maintain and manage the Labs' Quality Management System (QMS) documentation and records throughout the product lifecycle.
- Create and release documents based on input from quality and compliance teams to support new product introductions, production releases, clinical trials, and FDA submissions.
- Ensure documentation and data related to Quality System requirements are controlled for integrity and accessibility.
- Oversee document control activities such as version control, distribution, and reporting to ensure regulatory compliance.
- Facilitate communication between Operations, Supply Chain, and Engineering teams to ensure compliance with applicable medical device standards.
- Maintain records, including validation reports, test reports, exit reviews, and test results, per applicable regulations and standards.
- Support audits related to licensure and accreditation document submissions.
- Manage periodic document reviews and updates.
- Organize complex projects, solve document control-related issues, and provide status updates to cross-functional teams.
- Assist with the implementation of new electronic Quality Management Systems (eQMS).
- Provide end-user support and problem resolution for document control processes.
- Experience: 5 years in document control within a high-tech, fast-paced consumer electronics or medical device environment.
- Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, and CFR Part 11.
- Systems Proficiency: Experience with Teamcenter or similar PLM/Document Management systems.
- Technical Skills: Understanding of PLM processes and electronic document control systems.
- Software Proficiency: Familiarity with Google Suite.
- Industry Experience: Experience working in a regulated medical device environment.
- Comprehensive medical benefits
- Competitive pay
- 401(k) retirement plan
- ...and much more!
Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.
INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities
Salary : $30 - $45
