Quality Analyst

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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In this role, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to oversee quality for new product development. In this role, you will be the change champion in partnership with Engineers utilizing product line knowledge. Ensure that Edwards captures critical quality information necessary to maintain regulatory compliance. How you will make an impact:

• Collaborate with engineers to create complex change request packages and assess impact of the proposed change by performing thorough impact assessments utilizing PLM.
• Provide technical guidance utilizing moderately complex knowledge of product lines to make changes in drawings, parts, documents, protocols, and risk management in timely manner utilizing PLM
• Develop technical justifications and other content for engineering change submissions
• Evaluate and analyze moderately complex technical information and data related to production quality indicators, identifying trends and driving factors, and recommending course corrections.
• Create 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 and present training materials for quality system related processes
• Other duties assigned by Leadership; Support corporate level project management, including support in continuous improvement projects. What you'll need (Required):
• Bachelor's Degree in Related field or equivalent work experience
• 3 Years experience related experience or equivalent work experience What else we look for (Preferred):
• Experience working in a medical device, healthcare, or a related environment or equivalent work experience
• Proven expertise in MS Office Suite, Windchill PLM or equivalent
• Good project management skills and related software tools preferred
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Good problem-solving and critical thinking skills
• Knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Knowledge of Good Documentation Practices (GDP)
• Full understanding of medical devices regulations (e.

g., FDA (21 CFR Part 820) and

ISO13485

)

• 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
• Ability to adapt to new technologies and rapidly changing environment
• 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
• Position is located in Irvine with consideration for hybrid based out of corporate office, or US based remote.

Aligning 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. For California (CA), the base pay range for this position is $74,000 to $104,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require

COVID-19

vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.