Lead the administration of the Document / Record Control and the Training systems of the Quality Management System in the Chelmsford Facility, by providing technical and supervisory subject matter expertise.
- Supervise personnel from the Document Control and Training departments.
- Oversee the Document Control and Change Management processes which include, but not limited to the following:
- Maintain engineering drawings, project reports, specification preparations, documentation, special catalogs, and files for unique projects.
- Manage the process of assignment and monitoring of document numbers.
- Update and revise operating procedures as approved through Change Management.
- Manage the documentation process in Agile and SAP.
- Manage distribution process of controlled documents.
- Assist in the remediation of documentation files.
- Provide support in editing and updating documents and electronic filing databases.
- Participate and manage data entry and maintenance of records.
- Support the development of all types of documents and reports.
- Provide training and mentoring to document control personnel on the change management process.
- Lead and maintain the Training system via the following tasks:
- Maintain the training database.
- Generate Key Performance Indicators, KPI?s reports on associated on-time training and provide reports related to outstanding and delinquent training to management and supervisory personnel.
- Provide training and mentoring to training personnel on the training process.
- Provide expertise and service to external and internal customers in relation to the Change Management, Document Control and Training processes.
- Participate and support the Internal Audit program.
- Provide support during external audits and timely access to the documentation and records.
- Perform additional tasks as applicable, as assigned by the Quality Assurance Manager.
Education / Experience Requirements
- High School diploma (Associates degree preferred).
- 4 years of experience in positions that require documentation and technical writing and exposure to a training environment.
Specialized Skills / Other Requirements
- Proficient with Microsoft Office, including Word, Excel, Powerpoint and Outlook.
- Good negotiation, problem-solving and project management skills.
- Strong attention to detail and ability to meet deadlines.
- Effective communication skills, both written and verbal.
- Ale to work in a fast-paced dynamic environment.
- Knowledge of Quality Management Systems under ISO 13485:2016
- Experience in the medical device industry as an internal auditor.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
How To Apply
Please email your resume to firstname.lastname@example.org for consideration