Job Description

Edwards Lifesciences is seeking a Quality Analyst to join our New Product Development Supplier Quality team at our Draper, Utah site! This person will ensure that we have the key quality information necessary for regulatory compliance.

Key Responsibilities:

• 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
• Maintain supplier quality files
• 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, complete supplier quality requirements, etc.

Required Qualifications:

• Bachelor\'s Degree in related field with at least 3 years of previous related experience Required

Preferred Qualifications:

• Experience working in a regulated environment
• Experience creating dashboards and/or using Power BI or SQL
• Experience with data analytics
• Strong presentations skills
• 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/control

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards 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