Quality Management Systems Engineer

2 weeks ago

Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
Job Overview

ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is pioneering a unique medical device aimed at enhancing the lives of individuals suffering from Obstructive Sleep Apnea (OSA). Our innovative, FDA-approved solution is transforming the sleep industry by alleviating OSA symptoms for those who struggle with traditional CPAP therapy. We prioritize patient outcomes and are driven by a commitment to improving the lives of those seeking alternative treatments for sleep apnea.

WHY JOIN OUR DYNAMIC TEAM

At Inspire, we celebrate diversity and value the unique experiences and perspectives of our team members. We foster an inclusive environment that promotes continuous learning and professional growth, creating a community that thrives together. Our people-first culture is reflected in our hybrid work arrangements, comprehensive benefits, 401k matching, Employee Stock Purchase Plan (ESPP), flexible time off, and tuition reimbursement programs.

ABOUT THIS ROLE

The Quality Systems Engineer will focus on educating and guiding employees in fundamental quality principles, fostering a culture of continuous improvement, and ensuring the effectiveness of Inspire's Quality Management System. This role involves training staff on compliance with international regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR (2017/745), among others. Responsibilities include developing training materials, delivering educational sessions, and collaborating with subject matter experts within the Quality organization.

KEY RESPONSIBILITIES

  • Assess and identify training needs related to compliance and quality systems based on business requirements and regulatory risks.
  • Collaborate with subject matter experts to design core training programs for employees new to medical device compliance.
  • Assist in creating methods to verify the effectiveness of training and develop functional curricula for the organization.
  • Produce quality training resources, engaging learning activities, and case studies for classroom settings.
  • Develop and implement e-learning content for use with learning management systems.
  • Instruct employees on Quality Management System processes, core principles, and compliance-related factors.
  • Provide regular updates on training effectiveness to the Quality Management team.
  • Support training initiatives related to Corrective and Preventive Actions (CAPA) as needed.
  • Organize and schedule training sessions for staff.
  • Engage in team meetings and training sessions related to the Quality Management System.
  • Participate in internal audits of the Quality Management System as assigned.

QUALIFICATIONS

  • Bachelor's degree in a technical or scientific discipline, preferably in engineering.
  • A minimum of 3 years of experience in the medical device or pharmaceutical industry.
  • At least 2 years of experience in an engineering role related to medical devices, such as research, design, development, testing, manufacturing, regulatory affairs, or quality assurance.
  • Over 3 years of experience in developing training programs for both classroom and eLearning formats focused on quality principles and practices.
  • Proven leadership and project management abilities, with a strong capacity to prioritize and execute tasks effectively.
  • Excellent project and time management skills, capable of handling multiple tasks with shifting priorities.
  • In-depth knowledge of International and FDA Quality System Requirements.
  • Proficient in Microsoft Word, Excel, and PowerPoint.

PREFERRED QUALIFICATIONS

  • Master's degree in a technical or scientific field.
  • 10 years of experience in a quality or regulatory role within the medical device or pharmaceutical sectors.
  • Demonstrated expertise in ISO and FDA Quality System Requirements.
  • Proficient in employing creative and effective instructional techniques for compliance training.
  • Familiarity with additional Microsoft applications (e.g., Power BI, SharePoint, OneDrive).
  • ISO 13485 certified auditor.
  • ASQ certifications such as CQE or CQA.

Inspire Medical Systems is committed to providing equal employment opportunities to all employees and applicants, without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, or any other status protected by law. This policy applies to all aspects of employment, including recruitment, hiring, promotion, and training.

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