Document Specialist and Quality Systems Analyst, M&S Technologies

2 weeks ago


Niles, United States Hilco Vision Full time

Hilco Vision is an industry leading global eyewear/eye care company delivering comprehensive solutions to customers, built on a platform of innovation and operational excellence. It has direct subsidiaries in the USA, Canada, UK, Germany, Australia, China, Hong Kong, Belgium and the Netherlands. The company's product portfolio encompasses Prescription Safety, Lenscare, Eyewear Accessories, Lab & Dispensing, Ocular Surface, Exam Supplies, and Vision Testing.

Hilco Vision is searching for a meticulous and detail-oriented Document Specialist and Quality Systems Analyst to join our Quality Assurance team. This role is pivotal in managing and maintaining the documentation and quality systems that ensure our products and processes meet industry standards and regulatory requirements. The ideal candidate will have a strong background in quality management, document control, and data analysis.

If you're up for the challenge, we'd love to hear from you

Qualifications

  • Bachelor's degree in Quality Management, Engineering, Business Administration, or a related field.
  • Experience: 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, FDA regulations, etc.).
  • Proficiency in document management software and quality data analysis tools.
  • Excellent analytical, organizational, and communication skills.
  • 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.
  • May require occasional travel for audits and training.
Responsibilities
  • Document Control:
    • Manage the creation, review, approval, distribution, and archiving of controlled documents, including Standard Operating Procedures (SOPs), work instructions, quality manuals, and technical documents.
    • Ensure all documentation is compliant with industry regulations, company policies, and quality standards.
    • Maintain document databases and systems, ensuring accurate and up-to-date records.
  • Quality Systems Management:
    • Develop, implement, and maintain quality management systems (QMS) to ensure compliance with ISO 9001, ISO 13485, FDA, and other relevant standards.
    • Conduct regular audits of quality systems and processes to identify areas for improvement and ensure continuous compliance.
    • Coordinate with cross-functional teams to implement corrective and preventive actions (CAPA) and track their effectiveness.
  • Data Analysis and Reporting:
    • Analyze quality data, including non-conformance reports, audit findings, and customer feedback, to identify trends and areas for improvement.
    • Prepare and present quality performance reports to management, highlighting key metrics and recommendations for enhancement.
  • Training and Support:
    • Provide training to employees on document control procedures, quality systems, and regulatory requirements.
    • Serve as a point of contact for internal and external audits, providing necessary documentation and support.
  • Continuous Improvement:
    • Collaborate with other departments to develop and implement process improvements that enhance product quality and operational efficiency.
    • Stay updated on industry trends, regulatory changes, and best practices in quality management and document control.

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