Quality Engineer

Flexible & Integrated Technical Services

Dorado, PR
Permanente
Tiempo completo

Hace 9 horas
Postúlese fácilmente

For Remediation services in the Quality Assurance area.WHAT MAKES YOU A FIT:The Technical Part:

Bachelor’s Degree in Engineering and 3 - 4 years of experience in the review and approval of life cycle validation documentation in the regulated industry.
Bilingual: Spanish and English
Soft Skills: Attention to detail, organization, and writing skills.
Shift: Administrative, and according to business
Experience:

Validation Master Plans.
Standard Operating Procedures (SOPs)
Change Controls
Protocols
User Requirements Specifications (URS)

The Personality Part:Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

Responsible for the review and approval of validation and qualification protocols, specifically software validations.
Interacts with several functional departments, including IT, Manufacturing, and Quality.
Follow procedures, specifications, and standards for the site.
Ensure that process development and procedures comply with regulations.
Customer-focused and able to work under minimal supervision.
Generate and execute Process Validation based on equipment capabilities.
Support investigation task items, CAPA’s Change Controls, and trend evaluation.
Provide documentation and timely resolution of exception documents based on CAPA requirements.
Participate in site meetings to ensure timely identification and management of site events.
Perform Track and Trend of investigations to identify quality issues trends.

WHO WE ARE:We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent. We're FITS!Are you the next piece?Powered by JazzHR

Flexible & Integrated Technical Services