Sobre este puesto de Sr. Manager, QMS & Compliance en Inspire Medical Systems Inc.
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. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
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 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!
POSITION SUMMARY
This position is a leadership role focused on overseeing and enhancing Inspire’s global quality systems. This position involves leading teams responsible for quality systems compliance, QMS training and audit, and configuration assurance. This role also includes eQMS development, implementation, and validation ensuring compliance with global regulations and driving continuous improvement.
This position requires strong collaboration across the organization and partners with Operations, Manufacturing, Regulatory Affairs, Training and Executive leaders ensuring strategic alignment in delivering results.
This position participates with other senior leaders to embed a quality-based culture across all functions, with a relentless focus on serving our patients and stakeholders. This position leads decision-making processes on operational matters that may impact quality while actively promotes awareness of regulatory and customer requirements throughout the organization.
MAIN DUTIES/RESPONSIBILITIES
- Lead and maintain an effective quality system which includes a strategic QMS structure, quality planning activities, execution and monitoring of all QMS processes
and metrics.
- Develop and implement the annual quality plan, quality objectives and quality metrics that drive business objectives, continuous improvement and compliance to global regulations.
- Lead the development and implementation of new electronic QMS process workflows to drive compliance with current regulations as well as new geographic regulations where products are, or planned to be, distributed.
- Manage teams interacting with external agencies (FDA, Notified Bodies, and
Competent Authorities) for inspections and compliance audits.
- Lead QMS continuous improvement projects to increase efficiency of the QMS and
drive organization compliance.
- Ensure QMS competency-based learning is in place for all QMS processes for both Inspire employees and contractors.
- Recruit, coach, mentor and develop top talent for the quality team.
EDUCATION/EXPERIENCE
- Bachelor’s degree in a technical or scientific field or Bachelor's degree in any discipline with a minimum of 8 years experience in medical devices
- Minimum of 5 years in a medical device design assurance role, software quality assurance role and/or medical device post market role
- Extensive knowledge on complaint handing and global vigilance requirements for ISO, FDA and European Medical Device Regulations/QMS Requirements and other OUS geographies (e.g. ISO 13485; 21 CFR Part 820.198, 820, MDR, JPAL)
#LI-Onsite
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
- Multiple health insurance plan options.
- Employer contributions to Health Savings Account.
- Dental, Vision, Life and Disability benefits.
- 401k plan + employer match.
- Identity Protection.
- Flexible time off.
- Tuition Reimbursement.
- Employee Assistance program.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
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, pregnancy or childbirth, 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 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.
