Quality Applications Spec

Weil Group • Villalba, PR

1d

About The Position

Quality role to support product transfer activities, focus on sterilization machines, validation and process. Experience with process failure mode analysis and first time quality.

Requirements

• Knowledge on Sterilization Machines
• Process Validation, Statistical Analysis, Process Failure Mode and First Time Quality
• Engineering Degree
• 3yrs - 6yrs Experience
• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Requires a University Degree and minimum of 3 or more years of relevant experience, or advanced degree with 0 years of experience.

Responsibilities

• 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.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees