Edwards Lifesciences · 1 day ago
Senior Quality Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$106K/yr - $149K/yr
3+ years expEdwards Lifesciences is dedicated to innovation in healthcare, particularly in cardiac surgery. The Senior Quality Engineer will focus on implementing and optimizing quality engineering practices related to complaints investigation, post-market surveillance, and risk management to ensure compliance with global regulatory requirements and enhance product quality.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Investigate complex product quality and compliance issues (e.g. Product Risk Assessment, CAPAs, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports
Execute timely complaint investigations utilizing a multifunctional approach and ensuring issues are addressed in a systematic, methodical manner. Ensure investigations are adequate and comply with applicable procedures
Lead post-market surveillance activities to monitor safety, performance and effectiveness of products. Assess benefit-risk determination of devices throughout their entire life cycle. Complete review of post-market data and post market reporting activities (Eg. PSUR/PMSR) as required
Execute risk management activities through-out the post-market phase and ensure compliance with regulatory requirements. Support, update, and maintain technical content of risk management files and ensure integration with other aspects of the quality system
Other incidental duties assigned by Leadership
Qualification
Required
Bachelor's degree in Engineering or a related field and a minimum of 4 years of relevant industry experience, OR
Master's degree in Engineering or a related field and a minimum of 3 years of relevant industry experience, OR
Ph.D. in Engineering or a related field (no prior experience required), OR
An equivalent combination of education and experience as defined by Edwards criteria
Preferred
Proven expertise in usage of MS Office Suite; CAD experience preferred
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques will be required for work related plant sites
Previous experience working with lab/industrial equipment required
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Knowledge of and adherence to Quality systems
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 key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
A 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
BioWorld Financial Watch
2025-12-25
Medical Device Network
2025-12-25
Company data provided by crunchbase