Quality Engineer

For Quality Engineering services in the Quality area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least (5+) years of experience performing quality engineering functions within a manufacturing environment. 
• Bilingual: (Spanish and English). 
• Soft Skills: Problem-solving, excellent time management, and good decision-making.
• Shift: Administrative and according to business needs. 
• Experience in:
  • Fully bilingual (English/Spanish).
  • Verbal and Written Communication Skills
  • Review of all validation lifecycle documentation, procedures, change control, risk assessment, among other documents."
  • Capable of managing multiple tasks and prioritizing own workload
  • Intermediate skill in the use of Excel, Word, and PowerPoint; advanced preferred.

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 Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Provide support to Regulatory Affairs team in compiling, organizing, and managing EU MDR certification-related information pertinent to manufacturing sites operations.
• Collaborate closely with cross-functional teams to aid in the identification and resolution of deficiencies related to regulatory compliance, ensuring timely and effective resolution.
• Conducting investigation to identify the root causes, developing, and implementing actions to address process related issues.
• Stay up to date on changes, conducting risk assessment / gap assessments to identify potential process related risks / gaps.
• Collaborate with multifunctional teams to identify and implement process improvements!
• Developing and implement SOPs to ensure consistent and reliable manufacturing operations processes.
• Ensuring that processes are efficient, effective, and compliant with regulatory requirements and standards.
• Providing training and guidance to employees regarding regulatory compliance.

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?