Quality Systems Spec - 026

For Engineer services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Science and two (2) years of exposure within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Organization and Time Management Skills. 
• Shift: 1st Shift. 
• Experience in: 
  • Trackwise, and MAP Agyle tools. 
  • Change Control, CAPA, and documentation. 
  • FDA, GMP, ISO 13485, and GMP Regulations. 

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)

• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and performance.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet guidelines.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Coordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally..
• Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, and Medical Device Directive.
• Experience defining, driving, and implementing process improvement and functional excellence efforts.

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?