For Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Mechanical, Industrial, Electrical Engineering, or related field preferred, and four (4) years of exposure within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st & 2nd, and according to business needs.
- Experience in:
- FDA/ISO-regulated manufacturing environments
- Knowledge of validation and manufacturing processes
- Proficiency in problem-solving, risk assessment, and data analysis tools
- Experience with quality and business systems
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)
- Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment.
- Conducts quality assurance tests.
- Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research.
- Experience in manufacturing environments including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
- Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
- Proficiency in problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
- Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma certification and automation/programming experience are preferred.
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
- Four (4) years of exposure within the Medical Devices Industry
- Bachelor's Degree in Mechanical, Industrial, Electrical Engineering, or related field
- Bilingual: Spanish and English
- Excellent teamwork and communication skills
- Willingness to work 1st shift and as business needs require
- Experience in FDA/ISO-regulated manufacturing environments
- Knowledge of validation and manufacturing processes (equipment, process, product, software validation; IQ/OQ/PQ)
- Proficiency in problem-solving, risk assessment, and data analysis tools
- Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP)
- Experience with GMP compliance, ISO 13485, CAPA, nonconformance, change control, document control, and risk management
- Proficiency with root-cause and statistical methods (FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending)
- Lean Six Sigma certification
- Automation/programming experience
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]
