Junior Quality Systems Engineer
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Job Location:
Manchester, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Junior Quality Systems Engineer youll 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:
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 DEKAs 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 FDAs Quality System Regulation
- Knowledge of ISO 13485 and related standards
- Experiencewith Corrective and Preventive Action (CAPA)
Required Experience:
Junior IC
Key Skills
- Distribution
- Environmental Consultancy
- Access Control System
- ETL
- Art & Design
- Management Administration
About Company
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more
