- Recommend creative and efficient solutions while maintaining compliance to Inspire procedures and geographic regulations.
- Support and/or lead risk management activities from product concept through commercialization.
- Provide expertise, generate, and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents, supplier change request records, and Device Master Record (DMR) deliverables.
- Partner with Inspire manufacturing team to lead/support quality engineering activities with contract manufacturers (e.g., IQ, OQ and PQ support, non-conformance resolution, temporary authorities, and deviations, etc.)
- Collaborate and review clinical study protocols and regulatory submissions
- Ensure design history content integrity, completeness, and regulatory / standards compliance; Collaboratively communicate & resolve gaps with cross-functional team members.
- Provide quality engineering support for design changes and supplier changes.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Bachelor's degree in a technical or scientific field, preferable an engineering discipline
- 5+ years minimum experience in medical device
- Demonstrated creative and effective problem solving and original thinking for compliance solutions
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Ability to work on multiple tasks concurrently with changing priorities
- Knowledge of ISO and FDA Quality System Requirements (e.g., ISO 13485; ISO 14969; IEC 62304; FDA 21 CFR Part 820)
- 10+ years minimum experience in medical device
- Experience with multiple quality system functions (risk management, design assurance, manufacturing, post market surveillance)
- Experience with Class III active implantable products.
- Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
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Sr. Quality Engineer - Golden Valley, United States - Inspire Medical Systems, Inc.
Description
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
We are recruiting a Sr. Quality Engineer to join Inspire Medical Systems located in Minneapolis, MN. In this role, you will be a member of a small, cross functional team focusing on a strategic initiative. It will be a fast-paced environment where you will contribute to multiple different roles.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
WHAT YOU CAN BRING TO OUR GREAT TEAM
Required:
Preferred:
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 or email (dot)com
Inspire Medical Systems participates in E-Verify.
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 with regard to 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 an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at or email
