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For Validation services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Science or Engineering and (2) two years of experience within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent leader skills
- Shift: Administrative, and according to business needs.
- Experience in:
- Test Method Validation (IQ/PD/OQ/PQ) and CSV
- Manufacturing documentation changes
- Equipment Validation
- Equipment relocation and Incoming inspection.
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)
- Supports equipment and test method validation and supporting documentation as an author or quality reviewer.
- Supports process documentation changes as author or quality reviewer.
- Provides oversight of quality processes and procedures that ensure compliance with policies and the performance and quality of services.
- Guides in interpreting policies, regulatory regulations, and agency guidelines to ensure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
- Delivers projects assigned and works with other stakeholders to achieve desired results.
- The majority of time is spent delivering the projects while adhering to policies, using specialized knowledge.
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?
What you need to know about the Melbourne Tech Scene
Home to 650 biotech companies, 10 major research institutes and nine universities, Melbourne is among one of the top cities for biotech. In fact, some of the greatest medical advancements were conceptualized and developed here, including Symex Lab's "lab-on-a-chip" solution that monitors hormones to predict ovulation for conception, and Denteric's vaccine for periodontal gum disease. Yet, the thousands of people working in the city's healthtech sector are just getting started, to say nothing of the tech advancements across all other sectors.
