Quality Engineer

For Quality Engineering services in the Manufacturing and Quality Systems area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least five (5) years of experience to Quality activities within the Pharmaceutical or Medical Devices industry. 
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in Medical Devices, Lyophilization, Biomaterials, cGMP, Cleaning Methods, and Validation activities is preferred.
• Experience in:
  •  ISO Cleanrooms, Quality System Regulation (QSR), ISO standards, Design Controls, and Process Validation.
  • Qualification of facility systems including HVAC and water filtration systems.
  •  Statistical analysis and quality tools such as SPC, DOE, Process Capability, Gage R&R, and Minitab.
  • Lean Manufacturing, Six Sigma methodologies, Risk Management, and Root Cause Analysis.
  • Technical documentation development including Validation Protocols, Validation Plans, Investigations, SOPs, Change Controls, and Technical 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 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?

• Develop, implement, and maintain quality systems in accordance with FDA, QSR, ISO, and applicable regulatory requirements.
• Lead and support quality engineering activities related to manufacturing processes, facility qualifications, and process validations.
• Prepare, execute, and review validation protocols, validation plans, change controls, technical reports, investigations, and standard operating procedures.
• Support qualification activities for facility additions including HVAC systems, water filtration systems, cleanroom environments, and related utilities.
• Analyze quality and process performance data using statistical tools to identify trends, opportunities, and continuous improvement initiatives.
• Participate in internal and external audits, supporting audit preparation, execution, responses, and follow-up activities.
• Lead problem-solving efforts utilizing Root Cause Analysis, CAPA methodologies, and quality improvement tools.
• Collaborate with cross-functional teams to ensure product and process quality throughout the product lifecycle.
• Support risk management activities, reliability assessments, and quality planning initiatives.
• Drive Lean and Six Sigma initiatives to improve operational efficiency, compliance, and overall product 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?