Quality Engineer
Flexible & Integrated Technical Services, LLC
For Remediation services in the Quality Assurance area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Engineering and 5 years of experience in the review and approval of life cycle validation documentation in the regulated industry.
- Bilingual: Spanish and English
- Soft Skills: Attention to detail, organization, and writing skills
- Shift: Administrative, and according to the business
- Experience:
- Quality assurance focused on reviewing validation cycle documentation, quality systems, procedures, change control, and design control.
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?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Quality processes, including change assessments, process validations, and software validations, as well as experience in sterile packaging and labeling systems.
- Conduct and manage change assessments and process validations to ensure compliance with regulatory standards and company policies.
- Perform ESQ (Engineering Software Quality) and software validations to maintain high-quality software performance and reliability.
- Oversee sterile packaging processes, including final packing and labeling, ensuring adherence to safety and quality standards.
- Conduct inspections of labeling systems and processes to guarantee accuracy and compliance.
- Collaborate with cross-functional teams to identify and address quality issues, implementing corrective actions as needed.
- Utilize and maintain knowledge of systems such as Windchill, CAPA, MES, and BMRAM for effective quality management and documentation.
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 the well-being of our resources, 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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