Rachel Brennan
Stoneham
Summary
Skilled in managing and maintaining document control systems, ensuring compliance with regulatory standards. Demonstrated ability in streamlining processes, improving efficiency and reducing errors for organizations. Strong leadership skills with the capability to direct teams towards successful project completion while fostering a culture of continuous learning and improvement.
Overview
26
26
years of professional experience
4
4
years of post-secondary education
Work History
Document Control Manager
MEDICA
Bedford
11.1999 - Current
- Manage document control processes, systems and procedures per applicable Regulatory requirements. Ensure all documents within the Quality Management System are properly identified, reviewed, approved, and stored.
- Manage the employee training program. Develop or enhance training methods and / or matrices for employees and maintain training records.
- Develop and maintain document control procedures and related systems.
- Interfacing with the cross-functional departments to ensure proper document formatting, content, and compliance for all product and design documentation.
- Administrated the maintenance and updates of PLM (Omnify).
- Review and maintenance of the Device Master Records and Device History Records to ensure compliance with company procedures and Regulatory requirements.
- Supported R&D in phase design documentation and control. I.e. product specifications , risk management, design history file, design controls.
- Analyze and resolve document control issues. Prepare reports and audits to help identify document inconsistencies.
- Train employees in the use of controlled documents.
- Support internal and external audits as required. Other activities within the QA function as necessary.
Education
Drafting And Design
Northeast Metro Tech
Wakefield, MA 09.1992 - 06.1996
Some College (No Degree) - Architecture, Engineering
BAC
Boston, MASkills
- Proficiency in Microsoft Office Word, Excel, PowerPoint, SharePoint, OneDrive
- Knowledge of industry standards and regulatory requirements (FDA, IVDR)
- Familiarity with quality management systems (ISO13485/MDSAP)
- Electronic document management PLM (Omnify)
- Strong understanding of product Bill of materials, manufacturing, and quality
- Strong organizational and multitasking skills
- Excellent attention to detail and a 'do it right the first time' attitude
- Ability to prioritize and manage time effectively
Timeline
Document Control Manager
MEDICA
11.1999 - Current
Drafting And Design
Northeast Metro Tech
09.1992 - 06.1996
Some College (No Degree) - Architecture, Engineering
BAC