Quality Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

32d • Onsite

About The Position

For Quality Assurance services in the Manufacturing 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
• a minimum of three (3) years of exposure in Quality activities within the Pharmaceutical or Medical Device Industry.
• Excellent verbal/written communication skills (English and Spanish)
• Experience in Validation Life Cycle
• Experience in Change Control
• Experience in Documentation
• Experience in GMP & GDP regulations

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.

What This Job Offers

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