Supervisor, Document Control - CR
Position Overview
Supervise the document control department and maintain written documentation, including quality manual, design history files, device master records, device history files, and other documentation provided by the quality system. Job duties:
- Maintain document files to current requirements as defined by the quality system.
- Issue controlled document to the appropriate locations.
- Assist in the development of the document system and the quality document as directed.
- Maintain the training database.
- Assist Manufacturing Engineering and Quality Engineering team members in initiating document changes.
- Assist in designing and formatting document.
- Perform additional duties as assigned.
- Bachelor’s degree, or equivalent combination of education and experience
- A minimum of four (4) years of experience in document control for medical device manufacturing or regulated industry.
- Advanced proficiency Office skills including MS Word, Excel, and Office.
- Knowledge of Quality Med Device regulations and guidelines.
- Preparation of document, written and verbal communication skills, reading and preparing technical documentation.
- Computer skills including word Processing, spreadsheets, and databases.
- Good interpersonal skills.
- Organization and design of document systems for medical devices.
- Knowledge of Quality System Requirements.
- Supervisory experience.
- Bilingual both written and verbal.