Edwards Lifesciences · 17 hours ago
Senior Engineer, Supplier Quality
Salt Lake City, UT
Full-time
Onsite
Mid, Senior Level
4+ years expEdwards Lifesciences is a leading company focused on innovative technologies that improve patient outcomes. They are seeking a Senior Supplier Quality Engineer to lead and manage supplier qualification activities, ensuring product development and commercial launch timelines are met while collaborating with cross-functional teams.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Lead/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs
Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks
Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations
Manage component and supplier qualification activities from initiation to closure
Support component specification development, identification of critical features, development of inspection methods and plans
Support risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers
Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities
Conduct on-site supplier audits
Manage supplier-related non-conformances
Manage supplier corrective action requests (SCAR) from initiation to closure
Report on supplier part qualification status at recurring cross-functional project meetings
Collect and analyze Quality metrics relating to Supplier Quality
Communicate supplier quality risks to upper management during Management Review and project meetings and identify solutions to mitigate risks
Support process and system improvement projects as assigned by manager
Qualification
Required
Bachelor's degree in Engineering or Scientific field with at least four (4) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities; OR Master's degree with three (3) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities
Highly regulated industry experience
Must have ability to travel up to 25%
Preferred
Engineering degree
Medical Device, Aerospace, or Automotive industry experience
Knowledge and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards
Experience and/or proficient knowledge of Design Controls and test method development/validations
Demonstrated experience driving component testing, test method validations, and testing/validating equipment
Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies
Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs
Knowledge of GD&T and ability to read and interpret drawings
Good understanding of process validations (IQ, OQ, PQ)
Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.)
Good interpersonal skills, with the ability to negotiate and influence change
Possess the ability to multi-task, while maintaining high attention to detail
Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)
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
2026-01-07
Orange County Business Journal
2026-01-04
BioWorld Financial Watch
2025-12-25
Company data provided by crunchbase