Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. You will also ensure that Edwards has the key quality information necessary for regulatory compliance.How you will make an impact: Evaluate and analyze moderately complex technical information and data related to production quality indicators, identifying trends and driving factors, and recommending course corrections. Draft presentations and present summaries of trends, potential root causes, and recommended course corrections Draft updates to Quality procedures (e.g., inspection improvement initiatives), and conduct reviews to finalize procedures Contribute process knowledge to, and develop proposed modifications to resolve open issues on Quality, Engineering, and Manufacturing projects, as part of cross-functional technical groups Develop technical justifications and other content for Engineering Change Requests (ECRs) submissions Compile data and generate reports for Engineering and other internal customers Develop and present training materials for quality system related processes Other duties assigned by Leadership; Support corporate level project management, including representing the department in corporate level initiatives. Execute software validations impacting quality systems. Use JDE to put stop shipment holds on orders. ECRs) Support dashboard/tool development Identify data needs across department and develop solutionsWhat you'll need (Required):Bachelor's Degree in Related field3 Years’ experience related experience Experience working in a medical device, healthcare, or a related environmentWhat else we look for (Preferred): Good computer skills in MS Office Suite Good written and verbal communication skills including negotiating and relationship management skills Good problem-solving and critical thinking skills Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance Full knowledge of Good Documentation Practices (GDP) Good understanding of quality regulations Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $65,000 to $92,000(highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
