Document Specialist and Quality Systems Analyst, M&S Technologies

Hilco Vision - Niles, IL

Full-time - Mid Level

Niles, IL

About the position

The Document Specialist and Quality Systems Analyst at Hilco Vision plays a crucial role in managing and maintaining documentation and quality systems to ensure compliance with industry standards and regulatory requirements. This position is integral to the Quality Assurance team, focusing on quality management, document control, and data analysis within a regulated industry.

Responsibilities

• Coordinating and maintaining document databases (e.g., SharePoint or an electronic document management system)
• Ensuring documents comply with standards (i.e. ISO 13485:2016 for medical devices, QMSR, and EU MDR)
• Controlling the release, revision, and archiving of documentation
• Repairing and updating Standard Operating Procedures (SOPs), Work Instructions, and Quality Manuals
• Ensuring compliance through audits, both internal and external
• Working with quality and compliance teams to support continuous improvement initiatives
• Generating reports on document status, compliance metrics, and quality system performance indicators
• Identifying trends and reporting on non-conformances, corrective actions, and process improvements
• Analyzing audit results, non-conformance reports, and corrective actions for insights into QMS effectiveness
• Assisting with internal and external audits, including maintaining audit trails and compliance records
• Training personnel on document control procedures and quality management requirements
• Implementing corrective actions or improvement recommendations from audit findings
• Thoroughness and accuracy in document review, filing, and archiving
• Ability to organize and prioritize a large volume of documents and tasks
• Skills in reviewing documents for compliance with regulatory standards and company policies

Requirements

• Bachelor's degree in Quality Management, Engineering, Business Administration, or a related field
• Minimum of 3-5 years of experience in document control, quality systems management, or a similar role within a regulated industry (e.g., medical devices, pharmaceuticals, manufacturing)
• Strong understanding of quality management systems (ISO 9001, ISO 13485;2016, EU MDR standards, etc.)
• Proficiency in document management software and quality data analysis tools
• Excellent analytical, organizational, and communication skills
• Advanced proficiency in Microsoft Excel, Word, and PDF design and formatting
• Experienced creating and managing complex spreadsheets, developing well-structured documents, and designing professional, visually appealing PDF forms
• Ability to work independently and as part of a team in a fast-paced environment
• Detail-oriented with a strong commitment to accuracy and compliance

Benefits

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid holidays
• Paid time off