Supplier Quality Engineer II, Component New Product Development

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

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. The Supplier Quality Engineer II will play a key role on critical projects within the Surgical business unit.

This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection.

The primary focus of the position is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. Will also be responsible for resolving manufacturing quality issues, supporting CAPA/non-conformances, validating and improving processes, managing risk documentation, and driving Lean/Six Sigma improvements while ensuring regulatory and quality-system compliance. This role will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative is paramount to success.

How you will make an impact:

Facilitate/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. Manage component and supplier qualification activities from initiation to closure. Supports completion of Design File requirements applicable to supplied components, subassemblies, devices, and services. Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations. Conduct on-site supplier audits. Manage supplier-related non-conformances. Manage supplier corrective action requests from initiation to closure. Report on supplier part qualification status at recurring cross-functional project meetings.

What you’ll need (Required):

Bachelor’s degree in engineering or scientific field with at least 2 years of experience with either supplier quality, quality, manufacturing, or production engineering activities; OR Master’s degree with no experience (or internship/co-op experience). Highly regulated industry experience. Must have ability to travel up to 15% - 20%. Must be willing and able to work onsite 100%.

What else we look for (Preferred):

Engineering degree Medical Device, Aerospace, or Automotive industry experience. Experience and/or proficient knowledge of Design Controls and test method development/validations. 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.).

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $87,000 - $123,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.