Senior Supplier Quality Engineer

Drive corrective actions through use of various Root Cause tools (8D, 5 Why, etc), determining true root cause, implementing effective and lasting corrective and preventive actions. The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems.

Job Description:
The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service.

Responsibilities:

• Support Value Engineering and Quality Improvement Part Qualification efforts.
• Lead Core Product Teams in defining appropriate Part Qualification requirements.
• This includes defining testing and inspection requirements prior to system integration to maximize ISI factory efficiency.
• Support transfer of parts between suppliers.
• Complete Production Part Qualification Process deliverables: Supplier pFMEA, Special Process Validations, FAI, and Process Capability Analysis.
• Perform product/process risk analysis and ensure mitigations are implemented and effective prior to product introduction.
• Establish sustainable process capability at supplier and critical sub-tier suppliers.
• Support Manufacturing Line Escalations from manufacturing teams.
• Drive corrective actions through use of various Root Cause tools (8D, 5 Why, etc), determining true root cause, implementing effective and lasting corrective and preventive actions.
• Lead manufacturing process selection.
• Identify the correct process for manufacturing the part, considering process quality, long term capacity and total lifecycle cost.
• Identify where DFM is appropriate to achieve higher quality, lower costs or better supply chain capacity.
• Educate internal customers and suppliers regarding supplier quality, process and operational capabilities, best value. manufacturing methods and tooling for key supplier processes.

Education & Experience :

• BS degree in Engineering field.
• 10 years related experience in Manufacturing, Supplier Process Engineering, Design, or related field.
• Excellent written and verbal communication skills.
• Experience creating and aggregating DFM feedback.
• Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
• Experience with a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity.
• Desired product experience in the following categories:
• Machining, including 4 & 5-axis holdings, FMS and bar-fed lathes.
• Metal Fabrication, Welding and/or other bonding processes.
• Plastic Injection Molding or other plastic forming processes.
• Die casting or Thixomolding.
• Mechanical Motion Products (Bearings, Gears and Screws).
• Mechanical Motion Control Products (Motors, Brakes).
• Motion Control Sensors (Encoders, Inertial Sensors, Resolvers).
• Medical Gas Line Processing.
• Proven ability to motivate suppliers and lead teams to solve difficult technical and process problems.
• Knowledge of pFMEA, process validation, inspection and test techniques.
• Familiarity with 21 CFR part 820 and ISO 13485.
• Experience in auditing suppliers to these standards is preferred.
• At a minimum, candidate should understand GDP and QMS methods.
• Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP.
• Ability to read and interpret detailed specifications and schematics and communicate technical information.
• Experience in a medical device company is a preferred.
• Experience with low-volume high-mix production environments is a preferred.
• Ability to travel to suppliers on an as needed basis domestic and international.