Quality Analyst

Edwards Lifesciences

Quality Analyst at Edwards Lifesciences applying quality engineering principles and overseeing new product development compliance with regulatory standards.

Posted 5/21/2026full-timeIrvine • California • 🇺🇸 United StatesMid-LevelSenior💰 $74,000 - $104,000 per yearWebsite

About the role

Key responsibilities & 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

Requirements

What you’ll need

Bachelor's Degree in Related field or equivalent work experience
3 Years experience related experience or equivalent work experience
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

Benefits

Comp & perks

Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

impact assessmentstechnical justificationsdata analysisquality procedurestraining materials developmentproject managementGood Documentation Practicesmedical device regulationsFDA regulationsISO13485

Soft Skills

written communicationverbal communicationnegotiationrelationship managementproblem-solvingcritical thinkingattention to detailteam collaborationadaptabilitytime management