DEKA Research & Development · 1 week ago
Junior Quality Engineer
DEKA Research & Development is a company focused on innovation and cutting-edge technology. They are seeking a Junior Quality Engineer to ensure product quality standards are met, support the development of electromechanical devices, and participate in risk management and compliance activities.
3D PrintingDeveloper PlatformManufacturingMedical Device
Responsibilities
Ensure an overall level of product quality in line with DEKA’s standards
Support and participate in development of complex electromechanical devices
Assist in the development, implementation and approval of Device Master Records and Device History Records
Attain a comprehensive understanding of device design and core technologies, leveraging this knowledge to drive investigations and improvements in product design and process
Participate in investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis
Use critical thinking and analysis to determine the best approach and provide guidance on QMS, FDA Part 820, and ISO 13485 compliance to design team members
Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements
Qualification
Required
Aptitude for Learning Technical Information: Ability to comprehend and apply technical concepts effectively. Strong engineering foundation and technical skills
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
Effective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitude
Self-Motivated: Able to self-prioritize and work independently
Technical Writing: Proficient in conveying complex technical information clearly and concisely to a variety of audiences
Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio
BS or MS degree in Biomedical, Mechanical, Electrical, or a related engineering/ Science discipline
Ability to work as part of a multidisciplinary team
Excellent verbal and written communication skills, as well as attention to detail
Ability to understand and provide guidance on quality system procedures
Project coordination/ management skills
Technical Writing experience
Excel, Word, Visio skills
Preferred
Knowledge of FDA's Quality System Regulation
Knowledge of ISO 13485 and related standards
Experience with Corrective and Preventive Action (CAPA)
1+ years' experience in quality systems management, CAPA, quality assurance or a similar regulated environment
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
H1B Sponsorship
DEKA Research & Development has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (13)
2023 (23)
2022 (16)
2021 (9)
2020 (7)
Funding
Current Stage
Late StageRecent News
2025-10-10
NH Business Review
2025-03-26
Company data provided by crunchbase