Manager, Clinical QA/QMS

Cyberonics Houston, TX
Creating LivaNova and ultimately building a new premier medical device company has been an exciting time for us! In response to our growth, we have an opportunity for a Manager of Clinical QMS based out of Arvada, Colorado.

This position is a senior individual contributor role for the worldwide quality organization having business management responsibility for the global Clinical Quality Management System (QMS) and Clinical Audits. You will be working with the Clinical Program Managers, ensuring that all processes that are contributing to the performance of a clinical trial are conducted in accordance with the GCPs and other applicable regulations. The focus of the position is to manage all clinical quality assurance related activities, including the clinical QMS, training and auditing.

You will manage the global Clinical Quality Management System by maintaining and evolving it. You will also align the Global QMS and the Clinical QMS to new regulations by editing procedures in accordance with the regulations.

To do well in this job you must have recent medical device experience, specifically a minimum of ten years working in the medical device Regulatory and Quality field with five years of clinical trial experience. If you are currently working in a medical device clinic doing patient follow-ups and are participating in clinical trials, you will rock this job! You must possess a Bachelor's Degree in a scientific field or have equivalent working experience as mentioned above and a Lead auditor in QMS or GCP certification is preferred.

To be successful in this role, you must be self-motivated and self-disciplined. These are critical soft skills for the success in this role, and we want to see you succeed from the beginning.

Help us make a difference — join us in transforming patient lives with health innovation that matters.

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree, to a payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.