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)
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