Edwards Lifesciences · 21 hours ago
Quality Engineer II
USA - Utah – Salt Lake City
Full-time
Onsite
Entry, Mid Level
2+ years expEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Quality Engineer II position involves ensuring compliance with regulatory requirements, investigating manufacturing quality issues, and optimizing manufacturing processes to enhance product development and quality control.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Investigate moderately complex manufacturing product quality and compliance issues which may include:
Investigate PRAs and complaints for manufacturing related issues
Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results
Provide technical support to external land internal audits
Make recommendations and develop reports
Oversee product release, assess and disposition product onhold (MRB), and manage material quality control
Review and approve equipment validations and asset management actions
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Collaborate with engineering teams to ensure successful transfers
My develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Provides support to the following:
Process validation or support/lead TMV
Sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc
PMV, Process Validation plans
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
Other incidental duties assigned by Leadership
Qualification
Required
Bachelor's degree in an Engineering or Scientific field with 2 years of related experience, or a Master's degree with relevant internship, senior project, or thesis experience
Preferred
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
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 the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
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
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
Andrew Greene
Vice President, Strategy
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