Senior Supplier Quality Engineer

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.