At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world.
With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure.
Join us on our journey and make a meaningful impact on the lives of people around the globe.
Position Summary This position is responsible for the product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
In this role, you will interact with multiple Quality Management System stakeholders and Senior Leadership, in order to achieve timely releases of projects.
You will work with people's leaders to gain the commitment of cross functional resources, staffing CAPA projects and ensuring CAPA deliverables per project timelines.
Responsibilities and Duties Working effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.Promoting awareness and enthusiasm in the business for the CAPA process.Performing periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.Acting as a Project Manager with internal CAPA owners to manage all aspects of CAPA activities which include gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.Facilitating product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.Analyzing quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.Training and mentoring CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks.Performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.Ensuring CAPA action plans are robust and executed promptly, with the appropriate sense of urgency representing CAPAs during audits and CAPA Review Board meetings.Requirements Bachelor's degree in an engineering or scientific-related field or equivalent technical experience5 years' work experience in quality functionsDemonstrated expertise in problem solving tools and techniques.Working knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971.Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels.Ability to project manage all CAPA activities.Ability to assess risk as it pertains to the CAPA.Experience with CAPA is required.Salary range: $111,560 - $149,352 (Annual Base Salary)
The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions.
The expected base pay range for this role may be modified based on market conditions.
At Recor Medical, we care, we collaborate, we challenge, and we create.
Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology.
COVID-19 vaccines will be required for all Recor US office employees effective June 10, 2021, as well as all new US office employees joining our company.
Equal Employment Opportunity: At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Respecting your privacy is an essential part of the Company's privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant's application for employment, a Contract Worker's work, or a Former Employee's employment at Recor.
About UsAt Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world.
With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure.
Join us on our journey and make a meaningful impact on the lives of people around the globe.
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