Quality Assurance Systems Specialist

2 weeks ago

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

ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is pioneering a groundbreaking medical device aimed at improving the lives of individuals suffering from Obstructive Sleep Apnea (OSA). Our innovative, FDA-approved solution is designed to alleviate the severity of OSA for patients who find CPAP therapy intolerable or ineffective. We prioritize patient outcomes and foster a culture of determination to enhance 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 promote an inclusive environment that encourages professional growth and community building. Our people-centric culture includes hybrid work options, comprehensive benefits, 401k matching, Employee Stock Purchase Plan (ESPP), flexible time off, and educational reimbursement.

ABOUT THIS ROLE

The Quality Systems Engineer will focus on training initiatives, leading the development of core quality principles among employees, and fostering a culture of continuous improvement. This role is essential in ensuring the effectiveness of Inspire's Quality Management System by educating staff on compliance with international regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR (2017/745). Responsibilities include creating a foundational curriculum for all employees and specialized training programs.

KEY RESPONSIBILITIES

  • Assess and identify compliance or quality system training requirements based on business objectives and regulatory risks.
  • Collaborate with subject matter experts to develop training curriculums for employees new to medical device compliance.
  • Assist in creating methods to verify training effectiveness and develop functional curriculums for the organization.
  • Design quality training materials, interactive learning exercises, and case studies for classroom settings.
  • Produce and implement e-learning content using learning management systems.
  • Educate employees on Quality Management System processes, core principles, and compliance factors.
  • Provide regular updates on training effectiveness to Quality Management.
  • Support training initiatives related to Corrective and Preventive Actions (CAPA) as needed.
  • Organize, prioritize, and schedule training sessions for staff.
  • Engage in Quality Management System-related team meetings and training sessions.
  • 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, including research, design, development, testing, manufacturing, regulatory affairs, or quality.
  • Minimum of 3 years of experience in developing training programs for both classroom and eLearning formats, focusing on quality principles and practices.
  • Proven leadership and project management abilities, with a capacity to prioritize and execute tasks effectively.
  • Strong project and time management skills, capable of handling multiple tasks with shifting priorities.
  • Expert knowledge of international and FDA Quality System Requirements.
  • Proficient in MS 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 sector.
  • Demonstrated expertise in ISO and FDA Quality System Requirements.
  • Proven ability to utilize creative and effective instructional techniques, problem-solving skills, and innovative thinking for compliance solutions.
  • Familiarity with MS applications such as Power BI, SharePoint, and OneDrive.
  • ISO 13485 certified auditor.
  • ASQ certification; CQE, CQA, etc.

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

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