Flexible & Integrated Technical Services, LLC

Princ. Quality Systems Specialist - 123

Medical Devices - Juncos, PR, Puerto Rico - Contracted

For Engineer services in the Quality area.

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelor’s Degree in Engineering or Life Sciences and over eight (8) years of exposure within the Pharmaceutical & Medical Devices Industry.
Bilingual: Spanish and English
Soft Skills: Excellent Communication skills, and Positive attitude.
Shift: 1st Shift
Experience in:
- Quality Systems, including CAPA, Change Control, and Validations
- Medical Device Regulatory Requirements and compliance standards
- Quality and Regulatory Audit activities, including preparation, execution, and follow-up

The Personality Part:

Our Next Piece is someone who leads with empathy, communicates with clarity, and thrives in complex, collaborative environments. They coach others, solve problems creatively, and make a meaningful impact through trust and initiative. 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 oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies.
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
Work directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet guidelines.
Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all stages.
Coordinate legal requests in support of government investigations or litigations.
Ensure the quality assurance programs and policies are maintained and modified regularly.
Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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?