Senior Supplier Quality Engineer

Job Title

Pay Range: $61.67hr - $66.67hr

Requirement/Must Have:

• Bachelor’s degree in Engineering or a scientific field.
• At least 4+ years of engineering experience in a highly regulated industry (e.g., Medical Device, Aerospace, and Automotive).
• 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.
• 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.).

Responsibilities:

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

Skills:

• FDA 21 CFR Part 820.
• ISO13485.
• ISO9001.
• Design Controls.
• Test method development.
• Gage R&R.
• Statistical Process Control.
• Process Capability Studies.
• Root cause analysis.
• CAPA.
• GD&T.
• SolidWorks.
• IQ/OQ/PQ.
• Strong verbal and written communication skills.
• Ability to communicate effectively with stakeholders.

Qualification And Education:

• Ability to conduct effective root cause analysis.
• Ability to drive non-conformance investigations.
• Ability to multitask while maintaining high attention to detail.
• Ability to achieve results in a cross-functional team environment.
• Ability to build strong relationships with internal and external partners.