Junior Quality Engineer

DEKA Research & Development • Manchester, NH

1d

About The Position

Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Junior Quality 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. Quality Engineering is a high-visibility role with a significant, direct impact on the success of the project.

As a key contributor to our team, the following skills are 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 as variety of audiences.
Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio.

Requirements

• 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

Nice To Haves

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level