Quality Engineer

Flexible & Integrated Technical Services, LLC•Añasco, PR

7d•Hybrid

About The Position

For Quality Assurance services in the Manufacturing/Engineering area. 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?

Requirements

Bachelor's Degree in Engineering
at least three (3) years of previous exposure to Quality activities within the Pharmaceutical or Medical Devices industry.
Bilingual, Spanish and English (good communication)
Experience in Validation Life Cycle
Experience in Change Control
Experience in Documentation
Experience in GMP & GDP regulations

Nice To Haves

Customer service skills
Innovative mindset
Ability to deliver top-quality results

Responsibilities

Support the implementation of effective quality engineering processes for new products, processes, and technology.
Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
Works with multi-functional teams to establish project plans and ensure uninterrupted support to new projects balanced with manufacturing operations.
Develops standard operating procedures, specifications, and provides technical transfer and validation support.
Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.