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:
•2+ years of related experience.
•Proficiency in Microsoft Office, especially Excel.
•Ability to follow written procedures with accuracy and attention to detail.
•Ability to work autonomously.
•Associate or bachelor's degree in life sciences, engineering, or a related field preferred.
•Experience in a manufacturing environment preferred.
Preferred Qualifications:
•Previous experience using ETQ or other Document Management software.
•Knowledge of ISO 9001, ISO 13485, and 21 CFR 820 Quality Management Systems.
•Experience with continuous improvement initiatives.
•Strong attention to detail and accuracy in execution.
Location: Kennebunk, ME, USA, 04043
Education: Bachelors Degree