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.
- 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)
Top Skills
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
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