Senior Quality Engineer

The Senior Quality Engineer is accountable for assuring new or modified products are developed and released meeting customer expectations, regulatory requirements, appropriate standards, and Kestra policies and procedures. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, and system/services support.

Requirements

• Bachelor’s Degree in Engineering, Science, or technical field with 5+ years of work experience in Engineering and/or Quality.
• Minimum 3 years of proven ability with FDA regulated industry, preferably on product development programs.
• Significant experience in risk management throughout the product lifecycle, including strong working knowledge of 21 CFR 820.30, ISO 14971, EU MDR, IEC 62304, and cybersecurity.
• Demonstrated ability to utilize agile methodologies to arrive at difficult engineering decisions quickly.
• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) and Lead Auditor certification.
• Proficient in Microsoft Office programs.
• Excellent communication skills and proven ability to work as part of a team.
• Able to handle multiple tasks/projects and manage priorities accordingly.

Benefits

• Medical
• Dental
• 401K with Match