Quality Engineer

Flexible & Integrated Technical Services, LLC•Humacao, PR

13d

About The Position

The Quality Engineer provides Quality Engineering services for CTW and sustaining projects. As the Quality Engineering representative and a core project team member, this role leads quality activities throughout project initiation, execution, implementation, and closure. The engineer develops risk-based quality strategies, evaluates proposed product and process changes, and ensures change-control activities address product quality, patient and user safety, regulatory compliance, and the validated state. The role supports Design Control and risk-management activities; determines appropriate verification, validation, qualification, and testing requirements; and reviews technical protocols, reports, specifications, engineering studies, validation records, and change-control documentation. It also supports investigations and evaluates manufacturing process data using statistical techniques, ensuring project work complies with applicable FDA, 21 CFR Part 820, ISO 13485, GMP, and documentation requirements. The position has an administrative shift according to business needs.

Requirements

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

Responsibilities

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 address product quality, patient and user safety, compliance, and the 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 verification, validation, qualification, and testing requirements based on the nature and risk of proposed changes.
Review protocols, reports, engineering studies, test method validations, sampling plans, statistical analyses, and process and 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 on product quality.
Support investigations involving nonconformances, deviations, Quality Notifications, unexpected test results, and product or 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, ensuring decisions and rationales are scientifically justified, evidence-based, and compliant with Good Documentation Practices.