Job Summary:

• The Supplier Quality Engineer II will play a key role on critical projects within the Transcatheter Mitral & Tricuspid Therapies (TMTT) 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 part qualification efforts with external suppliers to support product development and commercial launch timelines. The Supplier Quality Engineer II will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are 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.
• Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.
• Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, process validations and component capability assessments
• Supports 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 from initiation to closure.
• 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

What you’ll need (Required Qualifications):

• Bachelor’s degree in engineering or scientific field with at least 2 years of experience with either supplier quality, quality, manufacturing, R&D or production engineering activities; OR Master’s degree in engineering or scientific field with no experience (or internship/co-op experience).
• Highly regulated industry experience.
• Must have ability to travel up to 25%

Targeted experience:

• Experience with Gauge R&R and Test Method Validation
• Preferably experience with process validations IQ, OQ and PQs
• Supplier quality management and receiving inspection experience
• Knowledge of statistical analysis. Specifically, process capability, PPK, P-value, and normality assessments
• Knowledge of the medical device and familiarity with manufacturing process
• Previously experience with creating RI routers new components
• Worked on NCR’s and supplier communication to troubleshoot

Systems used:

• Minitab, Microsoft Project, IGNITE/Windchill used for PLM, supplier systems like IQVIA/JD Edwards, Solidworks is a plus (3D is great)