Overview
Document Control Specialist / Quality Systems Specialist Jobs in Eden Prairie, MN at Kuro Medical
Job Summary
We are seeking a detail-oriented and highly organized Document Control Specialist / Quality Systems Specialist to join our dynamic team. In this pivotal role, you will manage and oversee the documentation processes that ensure compliance with industry standards and regulatory requirements. Your expertise will support the integrity of quality management systems, facilitate document workflow management, and uphold rigorous document control practices across various departments. This position offers an exciting opportunity to contribute to a fast-paced, innovative environment where precision and compliance are paramount. Your proactive approach will help streamline document management, enhance cross-functional communication, and maintain the highest standards of quality assurance.
Responsibilities
- Develop, implement, and maintain robust document control procedures aligned with ISO 13485, ISO 9001, FDA regulations, and pharmaceutical regulatory compliance standards.
- Manage document workflows using, ERP systems, and other document management systems to ensure timely review, approval, and distribution of quality documents.
- Conduct thorough document review processes to verify accuracy, completeness, and compliance with legal and regulatory standards in production.
- Organize and maintain electronic and physical filing systems for easy retrieval of records while ensuring data integrity and security.
- Collaborate with cross-functional teams to facilitate document approval processes, updates, and version control in accordance with project timelines.
- Perform proofreading and technical writing tasks to prepare clear, concise documentation including SOPs (Standard Operating Procedures), work instructions, and quality reports.
- Support records management initiatives by ensuring proper data entry, data management, and adherence to document compliance requirements.
- Assist in internal audits and inspections by providing accurate documentation trails and supporting evidence of compliance efforts.
- Utilize project management software to track document statuses, deadlines, and workflow progress efficiently.
- Maintain up-to-date knowledge of regulatory/legal compliance standards relevant to engineering industry documentation practices.
Experience
- Proven experience in document control within an engineering or manufacturing environment, preferably within the pharmaceutical or medical device sectors.
- Strong understanding of ISO 13485 (medical device quality management system), ISO 9001 (quality management systems), FDA regulations, and pharmaceutical regulatory compliance standards.
- Demonstrated proficiency with SharePoint, ERP systems, Microsoft Office Suite (Word, Excel, PowerPoint), and project management software tools.
- Experience managing complex document workflows while ensuring strict adherence to legal and regulatory requirements.
- Excellent organizational skills with a keen eye for detail; capable of managing multiple priorities simultaneously.
- Effective communication skills for cross-functional collaboration across departments such as engineering, quality assurance, regulatory affairs, and production.
- Background in technical writing or preparing detailed documentation for audits or inspections is highly desirable.
- Administrative experience involving records management, data entry accuracy, proofreading skills, and maintaining high standards of document integrity.
Join us in ensuring our quality systems are flawless! Bring your technical proficiency, organizational prowess, and passion for compliance to a role where your contributions directly impact product excellence and regulatory success.
Pay: $55,000.00 – $65,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
Title: Document Control Specialist / Quality Systems Specialist
Company: Kuro Medical
Location: Eden Prairie, MN
Category:
