What are the responsibilities and job description for the Technical Writer I Job at JobRialto in Kennebunk position at JobRialto?
Job Summary :
The Technical Writing role is responsible for managing quality management system documents and records in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards. This includes initiating document changes, distributions, and notifications. The role also involves updating procedures, working with various departments to improve processes, and assisting with other Quality Assurance functions as required. The candidate should be detail-oriented, autonomous, and proficient in Microsoft Office.
Key Responsibilities :
- Generate, review, and maintain quality system documents, such as procedures, work instructions, job aids, and certificates of conformance, in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiate Change Controls and Document Change Requests to update procedures and processes.
- Collaborate with various departments to update processes and procedures.
- Assist in managing the document review and retention processes.
- Support or lead continuous improvement initiatives for document control processes.
- Provide support for other Quality Assurance functions as needed, including internal audits and CAPAs.
- Fulfill internal and external document distribution and notifications.
- Perform other duties as required.
Required Qualifications :
Preferred Qualifications :
Location : Kennebunk, ME, USA, 04043
Education : Bachelors Degree
