Quality Engineer, Medical Devices – CAPA & Risk

Kelly Science, Engineering, Technology & Telecom; Arroyo (PR); On-site; USD 55,000 - 96,000; Part time

Job summary

Kelly® Engineering in Arroyo, Puerto Rico is seeking a Quality Engineer for a contract position to ensure quality and compliance of medical device products throughout the lifecycle. You will partner with cross-functional teams and drive the implementation of quality systems.

Responsibilities include risk management, CAPA, process validation, design verification, data analysis, audits, and mentoring junior engineers as needed.

Qualifications

• Bachelor’s degree in Engineering, or related field (Master’s preferred).
• 3+ years of quality engineering experience in the medical device industry.
• Experience in cycle validation.
• Strong knowledge of FDA regulations, ISO 13485, MDR, and other applicable standards.
• Proficiency in risk management, process validation, statistical analysis, and root cause analysis methodologies.
• Demonstrated ability to lead cross‑functional teams and projects.
• Excellent communication, documentation, and problem‑solving skills.
• ASQ certification (CQE, CQA, CMQ/OE) or Six Sigma Green/Black Belt preferred.

Responsibilities

• Lead and support risk management activities, process validation, and design verification in accordance with regulatory standards (e.g., FDA, ISO 13485, MDR).
• Investigate and resolve complex quality issues, including root cause analysis (RCA) and implementation of corrective and preventive actions (CAPA).
• Provide quality engineering support to manufacturing, design, clinical, and regulatory teams.
• Develop, review, and maintain process/product documentation, including procedures, work instructions, and control plans.
• Analyze quality data, monitor trends, and drive continuous improvement projects that enhance product quality and process reliability.
• Ensure compliance with internal and external requirements through audits, inspections, and documentation reviews.
• Champion risk-based thinking and prioritize patient safety in all quality decisions and actions.
• Serve as a mentor and resource to junior quality engineers and other cross‑functional team members.
• Facilitate training sessions related to quality system requirements and regulatory standards.

Skills

Quality engineering

Regulatory knowledge

Risk management

Process validation

Root cause analysis

CAPA

Documentation

Cross-functional leadership

Statistics

Six Sigma/ASQ

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Job description

Kelly® Engineering in Arroyo, Puerto Rico is seeking a Quality Engineer for a contract position to ensure quality and compliance of medical device products throughout the lifecycle. You will partner with cross-functional teams and drive the implementation of quality systems.

Responsibilities include risk management, CAPA, process validation, design verification, data analysis, audits, and mentoring junior engineers as needed.