Princ. Quality Systems Specialist - 123
Juncos, PR, Puerto Rico
Contracted
Medical Devices
Experienced
For Engineer services in the Quality area.
WHAT MAKES YOU A FIT: .png)
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?
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