Overview
Document Control Specialist Jobs in San Diego, California, USA at Modular Medical Inc.
The Document Control Specialist will be part of Modular Medical’s Quality team working with other team members to ensure compliance with the Quality System Regulations, ISO 13485 and other regulations as required. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives to support departmental, functional and company quality goals and priorities.
He/she can effectively communicate with all levels of the organization.
Role and Responsibilities
Control and maintain quality system documentation in accordance with internal procedures and external regulatory standards and guidance.
Administrator for all document and product change orders. Review submitted change orders for completion and work with other departments as required to ensure timely review of changes. Organize and run weekly Change Control Board (CCB) meetings and manage meeting action items.
Ensure that all employees are familiar with and follow document control procedures and good documentation practices. Perform training on these activities for new employees.
Manage and maintain employee training plans.
Control and maintain current version of Device Master Record documents on the production floor and with the contract manufacturer(s).
Organize and store quality records, enabling timely retrieval when necessary.
Create and revise company documents as requested.
Support both internal & external audits, including front/back room support and audit responses.
Assist with managing and record retention of clinical trial documentation.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Exercise judgment in planning and organizing work; monitors performance and reports status.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities, on occasion, as assigned.
Qualifications and Education Requirements Required
BS degree and/or equivalent combination of education and experience.
Minimum 3-5 years’ experience in the FDA regulated environment.
Work under minimal supervision. Relies on experience and judgment to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
Position Description
Experience with quality systems and standards compliance.
Familiarity with FDA/ISO and IEC standards and regulations.
Excellent verbal and written analytical/problem-solving, communication, negotiation, interpersonal and presentation skills.
Advanced personal computing skills, including SOP writing, and familiarity with common MS Office applications.
Ability to work with a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Multitasks, prioritizes and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to maintain regular and predictable attendance.
Preferred
Experience with an Electronic Quality Management System (EQMS).
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Title: Document Control Specialist
Company: Modular Medical Inc.
Location: San Diego, California, USA
Category: Quality Assurance – QA/QC (Regulatory Compliance Specialist)
