Supplier Quality Engineer II - Medical Device Impact

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a Supplier Quality Engineer II to lead parts qualification with external suppliers, ensuring design and process controls align with regulatory requirements. You will collaborate across R&D, Design Assurance, Operations, Regulatory Affairs, and Receiving Inspection in a fast-paced environment on critical projects.

Responsibilities include gage studies, test method development with SolidWorks fixtures, supplier audits, non-conformances, CAPAs, and risk

Qualifications

• Bachelor’s degree in engineering or scientific field with at least 2 years of supplier quality, quality, manufacturing, or production engineering activities; OR Master’s degree with no experience (or internship/co-op).
• Experience in a highly regulated industry is required.
• Must be able to travel up to 15–20% and work onsite 100%.
• Preferred: Design Controls, test method development/validation, and GD&T knowledge.

Responsibilities

• Lead supplier qualification activities from initiation to closure.
• Perform gage studies and process capability studies.
• Develop and validate test methods and fixtures (SolidWorks).
• Audit suppliers and manage non-conformances and CAPAs.
• Provide engineering support to Receiving Inspection.

Skills

Gage R&R

Statistical Process Control

Process Capability Studies

Design Controls

Root Cause Analysis

CAPA Investigations

GD&T

Reading Drawings

Education

Bachelor's degree in engineering or scientific field

Master’s degree with no experience

Tools

SolidWorks

Job description

Edwards Lifesciences is seeking a Supplier Quality Engineer II to lead parts qualification with external suppliers, ensuring design and process controls align with regulatory requirements. You will collaborate across R&D, Design Assurance, Operations, Regulatory Affairs, and Receiving Inspection in a fast-paced environment on critical projects.

Responsibilities include gage studies, test method development with SolidWorks fixtures, supplier audits, non-conformances, CAPAs, and risk