Junior Quality Systems Engineer

Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Junior Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.As a key contributor to our team, the following skills are required:

• 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.

As a Jr. Quality Systems Engineer, you will contribute in the following areas:

• 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.

Required Training / Knowledge: 

• 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)

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