• Technical Writing: Proficient in conveying complex technical information clearly and concisely to as variety of audiences.
• Aptitude for Learning Technical Information: Ability to comprehend and apply technical concepts effectively.
• Effective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitude.
• Project Coordination/Management: Skilled in planning, executing, and managing projects with varying timelines.
• Problem Solving: Embrace challenges and find creative solutions.
• Collaboration: Effectively collaborate with various teams and departments, sharing ideas, taking initiative and proactively contribute to achieve common objectives. Work to maintain a positive attitude, fostering a supportive and productive work environment.
• Attention to Detail: Display exceptional accuracy and precision in all tasks.
• Reliability: Consistently delivering high-quality work and demonstrating dedication to your role.
• Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio.

• Champion continuous improvement initiatives within the Quality Management System (QMS), actively seeking opportunities to enhance product quality and operational efficiency.
• Attain a comprehensive understanding of DEKA's products and processes, leveraging this knowledge to drive investigations and improvements within the QMS.
• Lead collaborative efforts in driving root cause investigations for Corrective and Preventive Actions (CAPAs), ensuring comprehensive analysis and appropriate solutions are implemented by cross-functional teams, while fostering a culture of technical understanding and problem-solving excellence.
• Support change management processes by developing and revising Standard Operating Procedures (SOPs) and associated change controls, ensuring alignment with regulatory requirements.
• Ensure compliance with FDA Part 820 and ISO 13485 regulatory standards, maintaining the integrity and effectiveness of the DEKA QMS.
• Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements.

• BS/MS in Science or Engineering
• Preferred 1 years’ experience in quality systems management, CAPA, quality assurance or a similar regulated environment
• Strong written/verbal communication skills
• Excel, Word, Visio skills
• Technical Writing experience
• Project coordination/management skills
• Aptitude for learning technical information
• Nice to have:
  • Knowledge of FDA’s Quality System Regulation
  • Knowledge of ISO 13485 and related standards
  • Experience with Corrective and Preventive Action (CAPA)

Job Summary