Job Description

Capstone Search Advisors is seeking a Quality Engineer who will play a key role in ensuring that medical devices are designed, manufactured, and distributed in compliance with regulatory requirements and company quality standards.

This position involves supporting design controls, process validations, risk management, CAPA, and continuous improvement activities to ensure patient safety, product efficacy, and compliance with FDA, ISO 13485, and other applicable regulations.

Key Responsibilities

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other regulatory standards.

• Participate in design control activities including design reviews, risk assessments (ISO 14971), verification, validation, and product transfers.

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and test methods.

• Support internal and external audits, inspections, and regulatory submissions.

• Lead and support CAPA, nonconformance, and complaint investigations, ensuring timely root cause analysis and effective corrective actions.

• Collaborate with manufacturing, engineering, R&D, and suppliers to ensure quality requirements are met throughout the product lifecycle.

• Perform statistical analysis and trending of quality data to drive continuous improvement.

• Provide quality support for supplier qualification, audits, and incoming inspection activities.

• Ensure compliance with documentation requirements including change control, SOPs, work instructions, and quality records.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.

• 2+ years of experience in quality engineering within the medical device or related regulated industry.

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485

• Experience with risk management, root cause analysis, and problem-solving methodologies (e.g., 5 Whys, Fishbone, FMEA).

• Hands-on experience with validation (equipment, process, and test methods).

• Proficiency in statistical methods and quality tools (Minitab or equivalent).

• Excellent communication, documentation, and collaboration skills.

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