Quality Systems Engineer - Software Compliance

Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our 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.

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

• Attain a comprehensive understanding of FDA's medical device software development requirements, leveraging this knowledge to champion improvement initiatives within the Quality Management System (QMS) and actively seeking opportunities to enhance DEKA's software development procedures.
• Develop and revise Standard Operating Procedures (SOPs) and associated change controls, ensuring alignment with regulatory requirements to support DEKA's software development processes.
• Lead collaborative efforts to drive internal investigations and improvements by ensuring comprehensive analysis and appropriate solutions are implemented by cross-functional teams.
• 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.

As a key contributor to our team, you will demonstrate the following skills :

• Technical Writing : Proficient in conveying complex technical information clearly and concisely to a 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 contributing 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.

Required Training / Knowledge :

• BS / MS in Science or Engineering
• Preferred 2+ years' experience in quality systems management, medical device, or a similar regulated environment
• Experience with software development (medical device preferred)
• Strong written / verbal communication skills
• Excel, Word, Visio skills
• Technical writing experience
• Project coordination / management skills
• Aptitude for learning technical information
• Must be able to work onsite Monday-Friday
• Nice to have :
• Knowledge of FDA's Quality System Regulation
• Knowledge of ISO 13485 and related standards

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