Quality Systems Engineer

3 months ago

Sacramento, California, United States Inspire Medical Systems Full time
About This Position

The Quality Systems Engineer will play a key role in ensuring the effectiveness of Inspire Medical Systems' Quality Management System by educating employees on compliance requirements of international regulations, such as ISO 13485, FDA 21 CFR Part 820, and EU MDR (2017/745). This position is responsible for creating a core curriculum for all employees and specific training programs, developing training materials, delivering instruction, and supporting training projects.

Key Responsibilities
  • Coordinate, analyze, evaluate, and suggest compliance or quality system training needs considering business needs and regulatory risk.
  • Work with subject matter experts to create core curriculums for employees new to medical device compliance.
  • Assist in developing training effectiveness verification methods and functional curriculums for the broader organization.
  • Create quality training materials, learning exercises, and case studies for classroom instruction.
  • Create and develop e-learning content for deployment through learning platform tools.
  • Train employees on QMS processes, core principles, and factors relevant to compliance.
  • Provide periodic QMS training effectiveness data to Quality Management.
  • Assist with training-related CAPA actions as assigned.
  • Plan, prioritize, and schedule training sessions for employees.
  • Participate in QMS-related team meetings and trainings.
  • Participate in internal QMS audits as assigned.
Requirements
  • Bachelor's degree in a technical or scientific field, preferably an engineering discipline.
  • Minimum of 3 years' experience in medical device or pharmaceutical field.
  • Minimum of 2 years' experience with medical devices in an engineering capacity such as research, design, development, testing, manufacturing, material science, regulatory affairs, or quality.
  • Minimum of 3 years developing training courses for both classroom and eLearning, on quality principles and practices.
  • Then providing expert instruction.
  • Demonstrated leadership and project management skills with the ability to prioritize and execute.
  • Strong project and time management skills, with the ability to work on multiple tasks concurrently with changing priorities.
  • Expert knowledge of International and FDA Quality System Requirements.
  • Proficient with MS Word, Excel, and PowerPoint.
About Inspire Medical Systems

Inspire Medical Systems is a company that values people and their diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

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