Junior Quality Systems Engineer
DEKA Research & Development
Location
Manchester, NH | United States
Job description
Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Junior 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.
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.
As a Jr. Quality Systems Engineer, you will contribute in the following areas: - 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.
Required Training / Knowledge: - 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)
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
Job tags
Salary
