Quality Systems Engineer
2 weeks ago
At DEKA Research & Development, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our quality team, you will play a critical role in ensuring the highest standards of quality and compliance in our software development processes.
Key Responsibilities:- Develop and revise Standard Operating Procedures (SOPs) and associated change controls to ensure alignment with regulatory requirements.
- Lead collaborative efforts to drive internal investigations and improvements, ensuring comprehensive analysis and appropriate solutions are implemented by cross-functional teams.
- 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 2+ years' experience in quality systems management, medical device, or a similar regulated environment
- Experience with software development (medical device preferred)
- Strong written/verbal communication skills
- Excel, Word, Visio skills
- Technical writing experience
- Project coordination/management skills
- Aptitude for learning technical information
DEKA Research & Development is a leading innovator in the field of medical device development. Our team of professionals strives to make a difference every day through thoughtful engineering, design, and manufacturing. We are committed to creating innovative and life-changing products that improve the lives of our customers.
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Quality Systems Engineer
3 days ago
Manchester, New Hampshire, United States DEKA Research & Development Full timeQuality Systems EngineerAt DEKA Research & Development, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our quality team, you will play a critical role in ensuring the highest standards of quality and compliance in our software development processes.Key Responsibilities:Develop and maintain a comprehensive...
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Quality Systems Engineer
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Manchester, New Hampshire, United States DEKA Research and Development Full timeDrive Quality Excellence at DEKA Research & DevelopmentAs a Quality Systems Engineer at DEKA Research & Development, you will play a critical role in driving quality excellence in our dynamic team. You will be responsible for ensuring the highest standards of quality and compliance in our software development processes.Key Responsibilities:Develop and revise...
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