For Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Engineering or Science and three (3) years of exposure within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st, and according to business needs.
- Experience in:
- Knowledge on Sterilization
- Knowledge in Final Pack
- Process Validation, Statistical Analysis, Process Failure Mode and First Time Quality
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)
- Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
- Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods to identify, implement, and maintain the procedures.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Performs system administration and configuration of quality information technology systems.
- Quality role to support product transfer activities, focus on sterilization machines, validation, and process.
- Experience with process failure mode analysis and first-time quality.
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?
Skills Required
- Bachelor's degree in Engineering or Science
- Three (3) years' experience in the Medical Devices industry
- Bilingual in Spanish and English
- Knowledge of sterilization processes and sterilization equipment
- Knowledge of final pack processes
- Experience with process validation
- Experience with statistical analysis for process/quality
- Experience with Process Failure Mode and Effects Analysis (PFMEA)
- Experience ensuring first-time quality metrics
- Experience conducting compliant validation for quality IT systems and producing validation documentation
- Experience with system administration and configuration of quality IT systems
- Strong teamwork and customer-service orientation
What We Do
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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
