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Regulatory Compliance Quality Engineer
2 months ago
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is pioneering a groundbreaking medical device aimed at improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our innovative, FDA-approved solution is transforming the sleep sector, specifically designed for those who struggle with traditional CPAP therapy. Our commitment to enhancing patient outcomes is central to our mission, and our proactive approach drives us to provide alternative solutions for sleep apnea.
WHY JOIN OUR DYNAMIC TEAM
At Inspire, we prioritize our people – valuing diverse experiences, backgrounds, and perspectives. We foster an inclusive environment that promotes learning and professional networking, evolving into a supportive community. Our people-first 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 developing and delivering training, leading initiatives to educate staff on fundamental quality concepts, and ensuring the effectiveness of Inspire's Quality Management System. This includes imparting knowledge on compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR (2017/745), and other relevant regulations. The role involves creating a foundational training curriculum for all employees and specialized training programs tailored to specific needs. This position collaborates closely with subject matter experts and the broader Quality team.
KEY RESPONSIBILITIES
- Assess, analyze, and recommend training requirements related to compliance and quality systems based on business needs and regulatory considerations.
- Collaborate with subject matter experts to develop core training programs for new employees in the medical device compliance sector.
- Assist in formulating methods to verify training effectiveness and develop functional curricula for the organization.
- Design quality training materials, engaging learning activities, and case studies for in-person instruction.
- Develop and implement e-learning content for distribution via learning management systems.
- Conduct training sessions on Quality Management System processes, core principles, and compliance factors.
- Provide regular updates on training effectiveness to the Quality Management team.
- Support training initiatives related to Corrective and Preventive Actions (CAPA) as required.
- Organize, prioritize, and schedule training sessions for staff.
- Engage in Quality Management System-related team meetings and training sessions.
- Participate in Internal Quality Management System Audits as assigned.
QUALIFICATIONS
- Bachelor's degree in a technical or scientific discipline, ideally 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 assurance.
- Over 3 years of experience in developing training programs for both classroom and eLearning focused on quality principles and practices.
- Proven leadership and project management abilities with a strong capacity to prioritize and execute tasks.
- 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 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 sectors.
- Demonstrated expertise in ISO and FDA Quality System Requirements.
- 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 equal employment opportunities for all employees and applicants, ensuring a diverse workforce. All employment decisions will be made without unlawful discrimination based on any protected status.
