Quality Engineer

Kelly® Engineering is seeking Quality Engineer for contract position at manufacturing client in Arroyo, Puerto Rico. If you’re passionate about bringing the latest professional discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring.

Position Summary:

As Quality Engineer, you will play a pivotal role in ensuring the quality and compliance of medical device products throughout the product lifecycle. You will partner with cross-functional teams, drive the implementation of quality systems, and facilitate continuous improvement to meet regulatory, company, and customer requirements.

• Key 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.

• 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.