Quality Engineer

FITS LLC; Humacao (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS LLC is seeking a Quality Engineer to support CTW and sustaining projects in a highly regulated medical device/pharmaceutical environment.

You will lead quality activities, assess changes, and ensure compliance with FDA 21 CFR 820, ISO 13485, GMP, Design Controls, and risk management. Bilingual Spanish/English is a plus and collaboration with cross-functional teams is essential.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical discipline; 3–5+ years of Quality Engineering experience in regulated manufacturing.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative & according to business needs.

Responsibilities

• Serve as Quality Engineering representative for CTW and sustaining projects.
• Provide Quality Engineering leadership during initiation, execution, and closure.
• Develop and execute risk-based quality strategies based on scope and regulatory requirements.
• Assess proposed changes to products, materials, suppliers, processes, and equipment.
• Lead quality impact assessments and ensure change-control activities address product quality and safety.
• Support Design Controls, risk management, validation, and TMV activities.
• Review and approve design reviews, validation documentation, and change records.

Skills

Quality engineering

Regulated industry

Bilingual Spanish-English

Education

Bachelor’s degree

Job description

For Quality Engieneering services in the CTW and Sustaining Projects area.

WHAT MAKES YOU A FIT:

THE TECHNICAL PART:

• Bachelor’s degree in Engineering, Science, or a related technical discipline, with 3-5+ years of relevant Quality Engineering experience in the medical device, pharmaceutical, or other highly regulated manufacturing industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • Sustaining engineering, CTW, change-control, or product lifecycle projects.
  • Design Controls, risk management, change control, verification and validation, process validation, and Test Method Validation (TMV)..
  • FDA Quality System requirements, 21 CFR Part 820, ISO 13485, and GMP requirements.
  • Reviewing and approving technical protocols, reports, specifications, risk assessments, FMEAs, validation documentation, and engineering change records.

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)

• Serve as the Quality Engineering representative and core team member for assigned CTW and sustaining projects.
• Provide Quality Engineering leadership throughout project initiation, execution, implementation, and closure.
• Develop and execute risk-based quality strategies based on project scope, product impact, regulatory requirements, and technical risk.
• Assess proposed changes to products, materials, suppliers, manufacturing processes, equipment, specifications, packaging, labeling, and related systems.
• Lead Quality impact assessments and ensure change-control activities adequately address product quality, patient/user safety, compliance, and validated state.
• Support Design Control activities, including assessment of design inputs, outputs, specifications, acceptance criteria, and design changes.
• Review and approve applicable design reviews, verification and validation documentation, risk-management deliverables, and change-control records.
• Determine appropriate verification, validation, qualification, and test requirements based on the nature and risk of proposed changes.
• Review protocols, reports, engineering studies, test method validations, sampling plans, statistical analyses, and process/equipment qualification documentation.
• Lead or support product and process risk-management activities, including FMEAs, risk assessments, risk controls, and Risk Management Files.
• Evaluate manufacturing process changes and associated data to assess process stability, capability, performance, and impact to product quality.
• Support investigations involving nonconformances, deviations, Quality Notifications, unexpected test results, and product/process failure modes.
• Apply statistical techniques such as process capability, SPC, hypothesis testing, confidence intervals, regression, ANOVA, measurement-system analysis, and acceptance sampling.
• Ensure projects comply with applicable Quality System requirements, including FDA requirements, 21 CFR Part 820, ISO 13485, GMP, Design Controls, Process Validation, and Test Method Validation.
• Author, review, and approve technical and Quality documentation while ensuring decisions and rationales are scientifically justified, evidence-based, and compliant with Good Documentation Practices.

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!

Are you the next piece?