Quality Engineer/Specialist

fitspr; Añasco (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS is a service provider delivering engineering, construction, maintenance, utilities and specialized technical services across the Island and in the US. We value family-like treatment for our resources, clients, and team members and hire people who deliver top-quality results.

The role focuses on initiating investigations and CAPAs, performing ETQ-based investigations for NR/CAPA events, and driving corrective actions with cross-functional teams to ensure regulatory compliance and product

Qualifications

• Bachelor's degree in Engineering or related field.
• At least 4 years of exposure to Audit Observations, Investigations & CAPA in a regulated industry.
• Bilingual Spanish and English.

Responsibilities

• 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.
• Identify and escalate compliance issues to Operations Managers for timely resolution.
• Reviews and analyzes quality trends with the manufacturing team.
• Consider quality trends to set work priorities for process enhancement.
• Provide leadership to cross-functional teams to ensure causes of non-conformance are identified and CAPAs implemented.
• Evaluate the implemented corrective and preventive actions against trends for effectiveness.
• Lead investigations of negative trends and facilitate implementation with Process Engineer and Manufacturing Manager.
• Analyze data and, based on trends, recommend actions for process, equipment, and system improvement.

Skills

Bilingual Spanish/English

NC/CAPA & Audit Observations

FDA 21 CFR regulations

GMP & GDP regulations

Education

Bachelor's Degree in Engineering

Job description

WHAT MAKES YOU A FIT:

THE TECHNICAL PART:

• Bachelor’s 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 you're 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 executeactions related to NC/CAPA & Audit Observations.
• Close the investigations and Product Dispositions on time.
• Identifies and escalatesto Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
• Reviews and analyzesquality trends with the manufacturing team.
• Consideringquality trends provides direction insetting work priorities for process enhancement.
• Provides leadership and guidance to cross-functional, multilevel technical teams to ensure thatcauses 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 the effectiveness of the same.
• Leads investigations of the negative trends and, in alignment with the Process Engineer and the Manufacturing Manager, facilitatesthe 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 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 industryclients with top-notch quality talent. We’re FITS!