Senior Quality Engineer (Software Design Controls)

Healthcare technology company focused on medical device software and Software as a Medical Device (SaMD) development.
$100,000 - $150,000
Quality Assurance
Senior Software Engineer
Hybrid
501 - 1,000 Employees
5+ years of experience
Healthcare · AI

Description For Senior Quality Engineer (Software Design Controls)

Tempus, a pioneering healthcare technology company, is seeking a Senior Quality Engineer to join their Quality Assurance team. This role is crucial in ensuring the quality and compliance of medical device software and Software as a Medical Device (SaMD) development. The position involves working with FDA's Quality System Regulation, ISO standards, and industry best practices.

The ideal candidate will play a vital role in maintaining and improving the software development life cycle (SDLC) and quality management system (QMS). They will be responsible for ensuring compliance with regulatory requirements while working in a fast-paced, innovative environment that focuses on Digital Health, Artificial Intelligence, and Machine Learning technologies.

Key responsibilities include managing documentation, risk assessment, validation processes, and supporting various quality assurance activities. The role requires a strong background in software quality assurance within the medical device industry, combined with excellent communication skills and the ability to work independently.

This is an excellent opportunity for a seasoned quality engineer who wants to make a significant impact in the healthcare technology sector. The position offers competitive compensation, including equity and medical benefits, and provides the flexibility of a hybrid work arrangement. Join Tempus to help shape the future of healthcare technology while ensuring the highest standards of quality and compliance.

Last updated 2 days ago

Responsibilities For Senior Quality Engineer (Software Design Controls)

  • Support Tempus' SDLC activities for medical device software and Software as a Medical Device (SaMD)
  • Maintain QMS procedures, identify improvement opportunities, and provide training
  • Ensure required documentation and DHF deliverables are generated and maintained throughout SDLC
  • Apply innovative, scalable and risk-based approaches to meeting compliance
  • Maintain knowledge of regulatory landscape for Digital Health, AI and ML technologies
  • Support compliance to various QMS procedures and activities
  • Participate in risk management, CAPAs, complaint/defect investigations, audits, and change control

Requirements For Senior Quality Engineer (Software Design Controls)

  • BA/B.S. or higher in Computer Science, Software Engineering, Biomedical, or relevant engineering disciplines
  • 5+ years in software quality role in medical device/IVD industry
  • Knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971
  • Experience with SDLC best practices and Atlassian (Jira) and Jama tools
  • Experience with Agile/Scrum/iterative software development methodology
  • Excellent organizational, interpersonal, verbal and written communication skills
  • Ability to work independently with minimal supervision

Benefits For Senior Quality Engineer (Software Design Controls)

Medical Insurance
Equity
  • Medical Insurance
  • Equity

Interested in this job?

Jobs Related To Tempus Senior Quality Engineer (Software Design Controls)

Senior Quality Engineer (Software Design Controls)

Senior Quality Engineer role at Tempus focusing on software design controls for medical devices and SaMD, requiring 5+ years of experience in FDA-regulated industry.

Senior Quality Engineer (Software Design Controls)

Senior Quality Engineer role at Tempus focusing on software design controls for medical devices and SaMD, requiring 5+ years of experience in FDA-regulated industry.

Senior Software Quality Engineer - VPG Creative Applications

Senior Software Quality Engineer position at Apple, focusing on testing and automating quality assurance for creative applications in the AR/VR space.

Senior Software Quality Engineer - VPG Creative Applications

Senior Software Quality Engineer position at Apple, focusing on testing and automating quality assurance for AR/VR applications with competitive compensation and benefits.

Software Quality Assurance Engineer, China Conn QA Team

Senior QA Engineer role at Amazon Lab126 focusing on consumer device testing, requiring 5+ years experience and strong technical skills.