Quality Engineer

For quality services in the engineering area.

About fitspr

• 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?

• 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?

Responsibilities

• Administrative & according to business needs.
• Capital Projects Cost Improvement Projects IQ/OQ/PQ validations or Product Transfers is preferred but not required.
• Quality Systems, Risk Assessments, and FMEAs.
• Change Management and impact assessments.
• Qualification and validation protocols/reports.
• Monitoring project progress and deliverables.
• AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Key Responsibilities include, but are not limited to, the following: Serve as the primary Quality Assurance (QA) support for day-to-day manufacturing operations.
• Collaborate with Line Supervisors, Investigation Quality Engineers, and Manufacturing Engineers to address manufacturing line opportunities.
• Serve as the QA Management Representative on the manufacturing line and work directly with the production workforce.
• Oversee procedural readiness, execution, remediation, and effectiveness.
• Track and report Quality Improvement actions and projects.
• Provide monthly reporting on quality improvement activities.
• Quality Improvement Projects, including initiating Change Requests / Change Orders as necessary.
• Ensure implemented changes are effective and sustainable.
• Provide support to Investigation Engineers as needed.

Requirements

• The Technical Part: Bachelor’s Degree in Engineering field and minimum of two (2) years of experience Quality and/or Compliance in the Medical Device or Pharmaceutical industry regulated industries.
• Bilingual (Spanish and English).

Benefits

• We are a Service Provider company different from the rest.