Company Overview Verigon is a leading contract electronic manufacturer specializing in mission-critical printed circuit board assemblies (PCBA), electronic components, and electro-mechanical assemblies designed for high reliability in demanding environments. We are dedicated to building strong relationships with customers who require comprehensive end-to-end supply chain and manufacturing solutions across various industries. Overview We are seeking a highly organized and detail-oriented Change Analyst - Document Control to join our dynamic team. In this role, you will be responsible for managing and maintaining all documentation related to quality management systems, regulatory compliance, and engineering processes. Your expertise will ensure that all documents adhere to industry standards such as
ISO 13485, ISO
9001, and FDA regulations, supporting our commitment to excellence and compliance. This position offers an exciting opportunity to contribute to critical projects within a fast-paced manufacturing environment while enhancing your skills in document management and cross-functional communication. Duties Oversee the control, review, and approval of technical documents, ensuring compliance with
ISO 13485, ISO 9001, FDA
regulations, and pharmaceutical regulatory standards. Manage document workflows using document management systems such as SharePoint and other project management software to streamline processes across departments. Maintain accurate filing systems for records management, including electronic and physical document storage, ensuring easy retrieval and audit readiness. Conduct thorough document review processes, including proofreading and data entry, to verify accuracy and completeness before approval or distribution. Collaborate with engineering, quality assurance, regulatory affairs, and production teams to facilitate cross-functional communication regarding document updates or changes. Ensure ongoing compliance with regulatory and legal standards related to document control within the manufacturing industry. Support project management initiatives by organizing documentation related to process improvements, audits, and validation activities. Qualifications Proven experience in document control within an engineering or manufacturing environment, preferably with exposure to medical device or pharmaceutical industries. Strong knowledge of
ISO 13485, ISO 9001, FDA
regulations, and pharmaceutical regulatory compliance standards. Proficiency in document management systems such as SharePoint; familiarity with Microsoft Office Suite (Word, Excel, PowerPoint). Excellent organizational skills with the ability to manage multiple projects simultaneously while maintaining attention to detail. Effective communication skills for liaising across cross-functional teams and ensuring clarity in documentation processes. Experience with technical writing, proofreading, data management, and records management is highly desirable. Demonstrated ability to handle confidential information with integrity and professionalism. Join us at Verigon where your expertise will help uphold our standards of quality and compliance while supporting innovative manufacturing solutions!
Pay:
$60,000.00 - $75,000.00 per year
Benefits:
401(k) 401(k) matching AD&D insurance Dental insurance Disability insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Referral program Tuition reimbursement Vision insurance