Senior Supplier Quality Engineer

Job Overview

Requirement/Must Have:

• Knowledge and understanding of FDA’s 21 CFR Part 820, ISO
  13485, ISO
  9001, 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.
• 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.).
• Good interpersonal skills, with the ability to negotiate and influence change.
• Possess the ability to multi-task, while maintaining high attention to detail.
• Ability to achieve results in a cross-functional team environment and build strong relationships with internal and external customers (suppliers).

Responsibilities:

• Lead/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 Solid Works.
• 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.

Qualification And

Education:

• 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).