Sr. supplier quality engineer

Roles & Responsibilities

• Support Value Engineering and Quality Improvement Part Qualification efforts.
• Lead Core Product Teams in defining appropriate Part Qualification requirements.
• Define 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 including 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 using root cause tools (8D, 5 Why, etc.), determine true root cause, and implement effective corrective and preventive actions.
• Lead manufacturing process selection 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.
• Drive improvements to ISI requirements by proposing and managing changes to specifications and drawings through the ECO process.
• Manage planning and implementation of supplier change management projects using the Supplier Change Request (SCR) process post Design V&V.
• Provide status of supply chain readiness (quality, capacity, delivery) for major production process changes.
• Work cross-functionally to improve supplier engineering processes.
• Support supplier selection by working with Product Design, Commodity Managers, and stakeholders to identify high capability suppliers.
• Evaluate new suppliers through informal and formal assessments, supporting lead auditors in QMS evaluations.
• Support audit teams in addressing findings to develop suppliers' quality and business systems.
• Manage supplier relationships to effectively partner with ISI suppliers.

Education & Experience

• BS degree in Engineering field.
• 10 years of 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 machining (4 & 5-axis, FMS, bar-fed lathes), metal fabrication, welding, bonding processes, plastic injection molding, die casting, thixomolding, mechanical motion products, motion control products, and sensors.
• Knowledge of pFMEA, process validation, inspection and test techniques.
• Familiarity with 21 CFR Part 820 and ISO 13485; experience auditing suppliers to these standards preferred.
• Understanding of GDP and QMS methods.
• Experience in a medical device company preferred.
• Experience with low-volume, high-mix production environments preferred.
• Significant computer experience using Windows, Word, Excel, Access, and ERP systems (preferably SAP).
• Ability to read and interpret detailed specifications and schematics and communicate technical information.
• Proven ability to motivate suppliers and lead teams to solve technical and process problems.
• Ability to travel to suppliers domestically and internationally as needed.