Quality Remediation Engineer / Specialist
Quality Remediation Engineer / Specialist
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Job Description
For Remediation services in the Quality Assurance area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineering or Science and two (2) years of experience in quality assurance or systems in the regulatedindustry.
- Bilingual: Spanish and English
- Soft Skills: Attention to detail organization and writing skills.
- Shift: Administrative and according to business
- Experience:
- Quality remediation activities.
- Rework qualification document revision & CAPA Support.
- Risk assessments document change management and compliance improvements.
- Electronic quality management systems (eQMS)
- FDA GMP & ISO 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 your (many) talents. Being the Piece means youre 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)
- Evaluate and qualify product and process reworks by approved protocols and regulatory requirements.
- Review and revise controlled documents (e.g. SOPs work instructions protocols batch records) as part of remediation efforts.
- Support impact assessments and risk analysis for nonconformances and historical deviations.
- Ensure that changes are documented appropriately with traceability and justification aligned with quality standards.
- Collaborate with cross-functional teams (Engineering QA Manufacturing) to gather required technical inputs.
- Participate in root cause investigations and implement corrective and preventive actions (CAPAs) where applicable.
- Maintain accurate records of all remediation activities and ensure timely completion of assigned tasks.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves on how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!
Are you the next piece
Required Experience:
Manager
Employment Type
Contract
