Quality Applications Specialist

Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
Requisitos:
Duties/Responsibilities: - Experience Process validation for New Product Introduction
- Problem solving method
- Risk assessment
- Ability to use statistical techniques to analyze data
- Capable of developing/reviewing/approving test plans and reports
- Experience in Medical devices manufacturing
- Interpersonal Skills
- Investigate and collaborate in the investigation of atypical events to support product disposition PFMEA

Work Shift (1st Shift Administrative 8 AM to 5 PM)

Education & Experience:

- Bachelor of Sciences with 2 to 5 years of experience in the Medical Device Industry.