Supplier Quality Engineer II

2 days ago


Irvine, United States JobRialto Full time
Job Summary:

The Supplier Quality Engineer II will play a critical role in driving quality initiatives within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This cross-functional position involves collaborating with multiple departments, including R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection. The primary responsibility is leading part qualification efforts with external suppliers to meet product development and commercial launch timelines. The role is fast-paced and dynamic, requiring proactive problem-solving and initiative.

How You Will Make an Impact:

• Facilitate and perform gage studies, process capability studies, and supplier process validations related to critical component features based on FMEA risk assessments.

• Develop and validate test methods, including creating inspection routines on optical measurement equipment and designing inspection fixtures using SolidWorks.

• Create test method procedures and provide training to team members.

• Provide engineering support to Receiving Inspection on component test methods and investigations.

• Support component specification development, identify critical features, develop inspection methods and plans, validate test methods, and conduct component capability assessments.

• Contribute to risk management activities, including FMEA development, process control plans, and quality agreements with suppliers.

• Use statistical techniques and Six Sigma tools to analyze processes and drive continuous improvement.

• Conduct on-site supplier audits and manage supplier-related non-conformances.

• Oversee supplier corrective action requests, from initiation to closure.

• Collect and analyze quality metrics related to Supplier Quality.

• Communicate supplier quality risks during Management Review and project meetings, and provide solutions to mitigate risks.

• Support process and system improvement projects as assigned by the manager.

What You'll Need (Required Qualifications):

• Bachelor's degree in engineering or a scientific field with at least 2 years of experience in supplier quality, quality, manufacturing, R&D, or production engineering activities; OR a Master's degree in engineering or a scientific field with no experience (or relevant internship/co-op experience).

• Experience in highly regulated industries.

• Ability to travel up to 25%.

What Else We Look For (Preferred Qualifications):

• Engineering degree.

• Experience in the Medical Device, Aerospace, or Automotive industries.

• Knowledge of FDA's 21 CFR Part 820, ISO 13485, ISO 9001, and other international regulatory standards.

• Experience in Design Controls and test method development/validation.

• Proficiency in statistical techniques such as Gage R&R, Statistical Process Control, and Process Capability Studies.

• Strong root cause analysis skills and ability to drive non-conformance investigations, corrective actions, and CAPA assessments.

• Knowledge of GD&T and ability to read and interpret engineering drawings.

• Understanding of process validations (IQ, OQ, PQ).

• Familiarity with manufacturing processes (e.g., injection molding, extrusion, machining).

• Strong interpersonal skills with the ability to influence and negotiate.

• Ability to multi-task while maintaining attention to detail.

• Ability to achieve results in a cross-functional team environment and build strong relationships with internal and external customers (suppliers).

Education: Bachelors Degree

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