Quality Systems Engineer - Training

ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people - your 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.

If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team!

ABOUT THIS POSITION

The Quality Systems Engineer will specialize in training, providing leadership by training employees in core quality principles, driving a continuous learning environment and ensuring overall effectiveness of Inspire's Quality Management System by educating employees on compliance requirements of international regulations, such as ISO 13485, FDA 21 CFR Part 820, EU MDR (2017/745) and other applicable regulations. This position is responsible for educating and driving employee compliance by creating a core curriculum for all employees and specific training programs. This position will develop training materials, deliver instruction, and support specific training projects. This position works closely with subject matter experts and the broader Quality organization.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Coordinate, analyze, evaluate, and suggest compliance or quality system training needs considering business needs and regulatory risk.
• Work with SMEs to create core curriculums for employees new to medical device compliance
• Assisting 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.

Required Qualifications

• 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 of 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 position in the medical device or pharmaceutical industry
• Demonstrated proficiency with ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; ISO 14971; FDA 21 CRF Part 11, 801, 803, 806, 812, 820, 821, 822, 830, 210, 211; Canadian Medical Device Requirements; European Directives, Japanese Ordinance 169, etc.)
• Demonstrated creative and effective instruction techniques, problem solving and original thinking for compliance solutions.
• Proficient with MS applications (i.e.; Power BI, SharePoint, OneDrive, etc.)
• ISO 13485 certified auditor
• ASQ certification; CQE, CQA etc.

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is anequal opportunityemployer with recruitment efforts focused on ensuring a diverse workforce.Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com

Inspire Medical Systems participates in E-Verify.

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