Quality Assurance Director- Healthcare is responsible for overseeing the quality management and quality improvement programs for a healthcare facility. Directs quality assurance and compliance functions. Being a Quality Assurance Director- Healthcare ensures that policies and initiatives are efficient, meet patient expectations and are updated to reflect regulatory changes. Requires a bachelor's degree. Additionally, Quality Assurance Director- Healthcare requires a certification of registered nurse. Typically reports to a top management. The Quality Assurance Director- Healthcare manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Quality Assurance Director- Healthcare typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)
DIRECTOR, QUALITY ASSURANCE
THE COMPANY:
Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.
SUMMARY OF ROLE:
We are seeking an experienced and dynamic Director of Quality Assurance to join our team. As the Director of Quality Assurance, you will play a pivotal role in ensuring the quality, safety, and compliance of our medical devices. You will lead a team of quality professionals and be responsible for implementing and maintaining a robust Quality Management System (QMS) to meet regulatory requirements and industry standards. The role will be managing Quality Control and the Quality Management System teams. Your leadership will drive a culture of continuous improvement and excellence in quality throughout our organization. This position reports to the Head of Quality Assurance.
RESPONSIBILITIES:
Quality Management System (QMS) Leadership:
Quality Operations:
Quality Compliance:
Audits, Compliant Handling and CAPA:
Quality Strategy and Continuous Improvement:
Team Leadership and Development:
Supplier Quality Management:
Quality Risk Management:
Cross-Functional Collaboration:
QUALIFICATIONS:
BENEFITS:
Element Science offers a very competitive salary and benefits package including, but not limited to:
The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.
At this time, we are unable to offer relocation assistance at Element Science.
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