Senior Supplier Quality Engineer

Part Qualification

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

Drive improvements to ISI requirements as necessary by proposing and managing changes to specifications and drawings through the ECO process

Manage the planning and implementation of supplier change management projects using the Supplier Change Request process (SCR) post Design V&V

Provide status of the readiness (quality, capacity, delivery) of the supply chain for major production process changes

Work cross-functionally to improve supplier engineering processes

Support Supplier Selection

Work with Product Design, Commodity Managers and other stake holders to identify high capability suppliers necessary for New Products based on assessment of business need and supplier capability.

Evaluate new supplies through informal assessments and formal assessment by supporting lead auditors in QMS evaluations

Support audit team in addressing findings to develop suppliers' quality and business systems in order to meet ISI's requirements

Manage supplier relationships to effectively partner with ISI suppliers

In order to adequately perform the responsibilities of this position the individual must possess:

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