Edwards Lifesciences · 4 days ago
Product Quality Clinician Manager
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$126K/yr - $178K/yr
8+ years expEdwards Lifesciences is a company focused on developing groundbreaking technologies that improve patient outcomes. The Product Quality Clinician Manager will provide clinical expertise and guidance to ensure product integrity and safety throughout its lifecycle, collaborating with various teams to optimize product development and resolve complaints.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.)
Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution
May provide training to complaint staff on patient anatomy and medical conditions, products and procedure, and internal policies and procedures
Perform complaint trending analyses, participate in quality metrics review meetings
May analyze and interpret aggregate complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report including ad hoc report summaries
Communicate complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations
Support process improvement projects as needed
Other incidental duties
Qualification
Required
Bachelor's Degree or equivalent in a related field or equivalent work experience based on Edwards criteria
Eight years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care RN, Practitioner, Physician, ICU, OR, or cardiovascular/endovascular interventions)
Preferred
Experience working in a large manufacturing company
Recent direct patient care in cardiac critical care or a cath lab, e.g., Registered Nurse, CST, PA, MD or Practitioner
Proven successful project management skills
Strong presentation and public speaking skills
Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Extensive understanding of FDA's Quality System Regulation
Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast-paced environment
Represents leadership on sections of projects within a specific area interfacing with project managers and quality compliance team
Consult in project setting within specific sections of quality compliance area
Provides quality compliance leadership to outsourcing partners on a task level
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
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
Company data provided by crunchbase