The Quality Document Control Manager responsibilities include the establishment and maintenance of the Document Control Quality Management System providing procedural framework for identifying, collecting, distributing and filing Insulets controlled documents and quality records. The position is engaged in improvement projects, ensuring efficient and compliant quality systems, and interfaces with all aspects of the business.
Process owner for Insulets Document Control Process. Ensures the information and management control system is implemented in compliance with regulation and standard requirements; and is updated to reflect revisions to those standards. Maintain awareness of new initiatives that may affect the control or distribution of information. Writes and maintains document control procedures and participating in the development and roll-out of document control tools. Manages and develops Document Control Specialists. Maintains a watchful and alert attitude toward Document Control, including developing routine reports and metrics to gauge success. Provide inputs to Monthly Data Analysis and Management Review, as required. Leads or participates as the QA representative in Document Control improvement projects and support of Internal / External Audit inspections. Maintains quality records and logs in compliance with FDA QSR and ISO 13485 standards. Performs other duties, as required.
Education and Experience
Minimum Requirements: High School Diploma Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) ISO 13485 quality system standards. Experience with FDA and ISO 13485 Certification inspections. Five years of document control experience, in a regulated industry. Working knowledge in an electronic Product Lifecycle Management system. Preferred Skills and Competencies: A four-year degree augmented with courses and/or seminars in engineering change control, change requests, contract administration, project management, or equivalent combination of education and work experience. Experience leading improvement projects Working knowledge of the Arena PLM system. Working knowledge of Microsoft Office programs (e.g. Word, Excel, Access, and PowerPoint). Experience in Adobe Acrobat. Effective verbal and written communication skills. Ability to communicate at multiple levels of an organization. Ability to generate and maintain organized and accurate records. Ability to manage, organize tasks and judge priorities. Must be able to interface with a variety of people with different technical levels and educational backgrounds; must be detail-oriented and highly organized; and must be able to produce accurate and timely results while maintaining a customer-service attitude. Must instill a can-do spirit within the Document Control Technician staff: inspiring them to produce consistently accurate results at a fast pace. Physical Requirements (if applicable): Ability to travel as business requires up to 5%. Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.