Edwards Lifesciences · 10 hours ago
Senior Quality Systems Analyst
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $127K/yr
5+ years expEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Senior Quality System Analyst is responsible for supporting all business units through the review, analysis, and evaluation of business needs to create solutions that align with overall business strategies.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Support Corporate Quality strategic initiatives by working with business representatives to understand, and document the business requirements, processes and workflows developing both written and visual depictions of requirements and process flows
Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems, manage conflicts and escalate as required
Work with IT to develop functional specifications and act as Subject Matter Expert for the proposed solutions
Work with the Corporate Quality PMO to ensure solutions are successfully developed, deployed and sustained in line with overall Corporate Quality objectives
Lead medium to large scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives in conjunction with Quality / Regulatory compliance requirements
Drive to resolve these issues completely and with speed by leveraging your network of key contacts outside your own area of expertise
You will suggest and drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation
Other incidental duties assigned by Leadership
Qualification
Required
Bachelor's Degree in related field, 5 years experience quality and/or manufacturing environment in the medical device industry OR equivalent work experience based on Edwards criteria required
Preferred
Proven expertise in MS Office Suite
Good project management skills and related software tools preferred
Excellent written and verbal communication skills including negotiating and relationship management skills
Strong problem-solving and critical thinking skills
Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
Full knowledge of medical or pharmaceutical regulations as relating to documentation
Full understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485)
Strict attention to detail producing high quality work
Ability to interact professionally with all organizational levels. Strong ability to manage and work with different cultures and nationalities, experience working in complex global environment
Ability to manage competing priorities in a fast paced environment, show initiative and be flexible
Working experience influencing others to action who are not direct reports
Work is performed independently on complex projects and reviewed for accuracy and soundness
Applies sound judgment when making decisions and communicating with peers and management
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
Competitive salaries
Performance-based incentives
Wide variety of benefits programs to address the diverse individual needs of our employees and their families
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase