Quality Analyst

Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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 patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring 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 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 youll need (Required):
Bachelors 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 $74000 to $104000 (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.