Quality Engineer

Flexible & Integrated Technical Services

Dorado, PR
Permanente
Tiempo completo

Hace 2 meses
Postúlese fácilmente

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

Bachelor’s Degree in Engineering or Science and two (2) years of experience in quality assurance or systems in the regulated industry.
Bilingual: Spanish and English
Soft Skills: Attention to detail, organization, and writing skills.
Shift: Administrative and according to business
Experience:

Quality remediation activities.
Rework qualification, document revision, & CAPA Support.
Risk assessments, document change management, and compliance improvements.
Electronic quality management systems (eQMS)
FDA, GMP & ISO regulations.

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)

Evaluate and qualify product and process reworks by approved protocols and regulatory requirements.
Review and revise controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation efforts.
Support impact assessments and risk analysis for nonconformances and historical deviations.
Ensure that changes are documented appropriately, with traceability and justification aligned with quality standards.
Collaborate with cross-functional teams (Engineering, QA, Manufacturing) to gather required technical inputs.
Participate in root cause investigations and implement corrective and preventive actions (CAPAs) where applicable.
Maintain accurate records of all remediation activities and ensure timely completion of assigned tasks.

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