Quality Engineer/Specialist
Quality Engineer/Specialist
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Job Description
For Quality servicesin the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degreein Engineering or related field and at least four (4) yearsof previous exposure to Audit Observations Investigations & CAPA activities within the regulated industry.
- Bilingual: (Spanish and English)
- Shift: Administrative & according to business needs
- Experience in:
- NC/CAPA & Audit Observations process
- FDA 21 CFR and global medical device regulations and standards
- GMP & GDP 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)
- Initiate NRs as required.
- Perform the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
- Plan and execute product disposition.
- Plan and Execute actions related to NC/CAPA & Audit Observations.
- Close the investigations and Product Dispositions on time.
- Identifies and escalate to Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
- Reviews and analyses quality trends with the manufacturing team.
- Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
- Provides leadership and guidance to cross functional multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
- Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
- Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager facilities the implementation process.
- Analysis of data and based on the trends recommends actions for process equipment and system improvement.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves in 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 our resources well-being 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
