Quality Engineer
Arecibo, PR, Puerto Rico
Contracted
Medical Device
Experienced
For Quality services in the Engineering area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s Degree and or an equivalent of two (2) years of experience in regulated industries.
- Bilingual (Spanish and English).
- Good organizational and problem-solving skills.
- Shift: Administrative & according to business needs.
- Experience in:
- Compliance and applicable regulations.
- Application and principles of Quality Engineering.
- Effectively communicate cross-functionally to assist with resolving Quality issues.
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)
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material.
- Leads identification of primary root causes for basic investigations, identifies appropriate corrective and preventive actions.
- Supports line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance.
- Owns basic to moderate exception / CAPA activities without oversight.
- May be responsible for working with process owner to bound product stops and document release criteria.
- Can perform lot to lot yield and rework evaluation.
- May be responsible for reporting of quality metrics.
- Understands product quality plans, documents, and quality systems.
- Develops product quality plans, documents and systems by providing input to product specifications, quality specifications.
- Quality plans, risk analyses, FMEAs in conjunction with other product development team members.
- May be responsible for owning and maintaining product risk analyses and FMEAs.
- Monitors process by using process monitoring tools and Infinity QS to reduce process variation
WHO WE ARE:
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 you the Next Piece?
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