The successful candidate will have experience working within quality management systems that are compliant with FDA’s Quality System Regulation, ISO 13485, ISO 14971, and IEC 62304. The Senior Quality Systems Engineer will be responsible for maintaining and improving RND’s Quality Management System (QMS) and ensuring its compliance with applicable regulations, standards, and guidance documents. Responsibilities also include participating in assessments of client QMS documents and Design History Files (DHFs) to determine compliance with applicable regulations, standards, and guidance documents.
Required Skills and Qualifications:
- A Bachelor’s degree
- Minimum of 4 years’ experience working with quality systems for regulated medical devices
- Strong understanding of and experience with FDA’s QSR, ISO 13485, IEC 62304, and ISO 14971
- Understanding of software development lifecycle processes
- Experience with internal and/or supplier audits
- Experience writing procedures, policies, and templates
- Experience with software verification and validation
- Excellent oral and written communication skills
- Demonstration of ability to work on a team
RND is a highly specialized software engineering firm dedicated to the FDA regulated medical device market. We work with companies by partnering with their product development organizations in providing project management, requirements management, software engineering, and product testing services as needed to complement our clients’ existing engineering departments.
RND develops software and provides regulatory consulting to assist with our client’s Next Generation medical device platforms and instruments. These platforms and instruments provide “breakthrough” technologies that are used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and perform research to assist with developing other healthcare solutions.
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