Senior Quality Engineer

For Project Management services in the Manufacturing area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Sicence and five (5+) years of experience in of the Medical Device or Pharmaceutical Industry.
• Bilingual: (Spanish and English)
• Soft Skills: Problem solving and effective persuasion skills. 
• Shift: Administrative and according to business needs.
• Experience in:
  • Manage all aspects of projects(s): planning, implementation, monitoring, completion, and follow-up. 
  • Proficient in Microsoft Excel data migration and Microsoft Word and PowerPoint. 
  • Product Transfer, Injection molding, and New Tooling. 
  • Quality Systems (CAPA’s, FMEA’s, Risk Assessments, Supplier Qualifications, Quality Audit, and  Non-Conformance Reports). 

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)

• Lead and support quality investigations including NCRs, complaints, and quality feedback, ensuring proper root cause analysis and resolution.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPA) to prevent recurrence of quality issues.
• Evaluate and analyze manufacturing and QA quality reports to identify trends, risks, and improvement opportunities.
• Monitor and report Quality KPIs (e.g., First Pass Yield, DPM, CPM) and drive initiatives to improve process performance.
• Support validation activities, including protocol development, execution, deviation management, and final reporting (IQ/OQ/PQ).
• Develop, review, and approve quality and engineering documentation such as SOPs, procedures, rework protocols, and validation documentation.
• Participate in product and equipment transfers, ensuring manufacturing readiness, documentation compliance, and successful startup.
• Lead and support continuous improvement and process optimization initiatives across manufacturing and quality systems.
• Conduct audits, lot document reviews, and process monitoring activities to ensure compliance with regulatory and quality system requirements.
• Ensure compliance with Quality System Regulations (QSR), GMP, safety policies, and regulatory standards while supporting training and quality. 

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?