Quality Engineer- 01

Flexible & Integrated Technical Services • Caguas, PR

17h

About The Position

For Quality services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree and or an equivalent of two (2) years of experience in regulated industries. Bilingual (Spanish and English). Good organizational and problem-solving skills. Shift: Administrative & according to business needs. Experience in: Non-conformance. Technical Writing. Validation Knowledge. Documentation, Compliance and applicable regulations. Effectively communicate cross-functionally to assist with resolving Quality issues. 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 of 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 Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Understands product quality plans, documents, and quality systems. Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other project team members. Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas. Write and approve protocols and reports with minimal management oversight to support engineering studies and validations. Can generate and approve qualification and validation protocols and reports with minimal oversight. Monitor progress and performance against the project plan. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in 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 our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Requirements

• Bachelor’s Degree and or an equivalent of two (2) years of experience in regulated industries.
• Bilingual (Spanish and English).
• Good organizational and problem-solving skills.
• Experience in: Non-conformance.
• Technical Writing.
• Validation Knowledge.
• Documentation, Compliance and applicable regulations.
• Effectively communicate cross-functionally to assist with resolving Quality issues.

Responsibilities

• Understands product quality plans, documents, and quality systems.
• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other project team members.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.

What This Job Offers

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