Quality Applications Specialist

Flexible & Integrated Technical Services, LLC • Villalba, PR

10d • Onsite

About The Position

This role is for Engineering services in the Manufacturing area. The ideal candidate will have a Bachelor's Degree in Engineering or Science with three (3) years of experience in the Medical Devices Industry. Bilingual proficiency in Spanish and English is required, along with excellent teamwork skills. The position operates on a 1st shift, with flexibility for business needs. Key experience areas include knowledge of Sterilization, Final Pack, Process Validation, Statistical Analysis, and Process Failure Mode and First Time Quality. The company culture emphasizes treating everyone like family, innovation, and delivering top-quality results. The company is a Service Provider integrating Engineering, Construction, Maintenance, Utilities, and Specialized Technical services, known for being flexible, family-oriented, and focused on employee well-being.

Requirements

• Bachelor’s Degree in Engineering or Science
• Three (3) years of exposure within the Medical Devices Industry
• Bilingual: Spanish and English
• Excellent teamwork skills
• Knowledge on Sterilization
• Knowledge in Final Pack
• Process Validation
• Statistical Analysis
• Process Failure Mode and First Time Quality

Responsibilities

• Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
• 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 to identify, implement, and maintain the procedures.
• 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.
• Quality role to support product transfer activities, focus on sterilization machines, validation, and process.
• Experience with process failure mode analysis and first-time quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level