Elephas, a Madison, WI-based biotechnology company, is seeking a highly motivated Quality/Regulatory Engineer with a focus on Software as a Medical Device (SaMD) to join our QA/RA team. A successful candidate will have a bachelor’s degree and be pursuing a career in Quality Assurance or Regulatory Affairs. This candidate will be self-motivated to learn and be comfortable in a fast-paced and highly collaborative environment. As a Quality/Regulatory Engineer at Elephas you will closely collaborate with a cross-functional team of Engineering, IT, and Product Management as you build and improve the Quality Management System (QMS).
Essential Duties and Responsibilities
- This position is an integral member of the QA/RA team.
- In this role, you will be responsible for ensuring documentation (e.g., DHF) and records within the QMS are complete and support development of software as/for/in a medical device application.
- Drive requirements of the FDA Quality System Regulation 21 CFR Part 820, ISO 13485 Quality Management System - Medical Devices, and 2017/745 and 2017/746 EU MDR/IVDR.
- Support product risk management activities for software (both pre-market and post-market)
- Knowledge of FDA’s trend in AI/ML and Digital Health Center of Excellence
- Provide support during inspections and audits, leading those related to software and AI/ML components.
- Build and implement Quality procedures within the QMS for software and AI/ML components
- Coordinate on regulatory and quality strategies and their execution, especially in support of software and AI/ML components
- Have a commitment and passion for product compliance, quality, and safety.
- Ability and desire to read, understand, and interpret regulations.
- Be(come) a Quality Management System (eQMS) superuser
- Support employee training activities
- Investigate quality events using root cause analysis tools.
- Perform other duties to support the QA/RA department as requested.
- Bachelor’s degree in life sciences, engineering, biotechnology, or related sciences preferred.
- Experience working in QA/RA specifically in support of SaMD development and operations.
- Experience with Software as a Medical Device (SaMD) and AI/ML
- Knowledge of Software Quality Engineering fundamentals a plus
- Strong understanding of Good Documentation Practices
- Computer proficiency of Microsoft Office Suite
- Excellent verbal, interpretation, and written communication skills
- Practical experience with varied business activities
- Work, shadow, and train alongside accomplished professionals
- Contribute to the formidable mission of Elephas
- Competitive compensation
Qualified candidates should forward their resumes to Mindy Costin firstname.lastname@example.org