Responsible for the corporate document control process, including working directly with authors, reviewers, and approvers to facilitate document control workflow, working directly with sites to implement corporate best practices documents, and providing corporate governance. Provides end-user support for the organization and manages use of the electronic document management system (eDM). Accountable and responsible for the management of all QMS (e.g. policies, procedures, etc.) and nonQMS related documentation and records. Responsible for ensuring compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485, etc.).
Principal Duties and Responsibilities
Facilitates the document control process regarding new or existing Corporate Quality System Documents, nonQuality System documents, and other related records; and tracking the status of documents during the process � draft, peer review, approved, effective, obsoleted, etc. This includes working directly with authors, reviewers, and approvers to facilitate document control workflow and document archiving/retention, assisting with document formatting, ensuring proper document organization; ensuring required metadata and other applicable data inputs for compliance are provided; and tracking and trending of open tasks to facilitate timely turn-around.
Conducts technical writing review of Corporate QMS documents prior to formal review process to ensure accuracy, good documentation practices, readability (clear & concise), and compliance to FDA and other standards and regulations. This includes identifying QMS gaps, providing guidance to document authors regarding how to create, or remediate or correct documents prior to their finalization and retention in the document management system or file.
As Author or Process Owner, creates, modifies and obsoletes QMS documents and corporate best practices procedures and policies, and creates and provides respective training presentations for global audiences.
Serves as eDM administrator and global Subject Matter Expert, and supports Corporate Document Control Manager with global governance.
Trains corporate and global team members on document and change control processes and eDM usage.
Assists in the preparation for, conduct of, and follow-up activities associated with site visits from FDA or other agencies.
Maintains required Standards / Regulations program and maintain Regulation/Standards utility subscription user accounts.
Expected Areas of Competence
�Action oriented, drives for and achieves results.
�Must be proficient in MS Office and Sharepoint.
�Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a class-room or workshop setting.
�Proven strong writing and editing skills.
�Proven excellent attention to detail and proofreading skills.
�Strong organizational skills and the ability to multi-task.
�Strong and effective communicator (written and verbal).
�Motivated and proven ability to work in a team-oriented, global environment, including interacting effectively with all levels and outside contacts.
�Excellent problem identification and solving skills.
�Sound decision making skills, solid under pressure.
�Effective process development and process management skills.
�BS/BA in engineering, business, life sciences or a similar discipline required.
�Minimum of 3 - 5 years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control or function in the medical device or life sciences industry.
�Working Knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS.
�Experience with electronic Document Management (eDM) systems is preferred.
�Prior experience of participating in compliance audits or inspections is preferred
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