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Abbott Senior Supplier Quality Engineer in Scottsdale, Arizona

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Job Summary

Supplier Quality Engineer will partner with Supply Chain, suppliers, manufacturing, and design transfer teams to prevent defects in purchased material. This position is responsible for Supplier Quality activities that improve, monitor and measure the quality of suppliers, purchased parts and purchasing controls. Designs methods and procedures for supplier acceptance, testing and evaluation of purchased materials. Drives improvement and corrective action in the quality of components sourced from outside suppliers which meet company and regulatory requirements. This individual will be a skilled and experienced Engineer who will work on complex medical device specifications and standards. This role will be responsible for directing activities related to development and maintenance of quality standards for medical device materials and processes within the Abbott supplier base.

Responsibilities

PROGRAM RESPONSIBILITY

  • Cultivates a wide range of internal networks and develops an extensive network of resources to facilitate completion of tasks

  • Influence exerted at peer level and senior level management

  • Leads development and implementation of Supplier Quality initiatives and improvements within Abbott supplier base

  • Leads in maintenance and improvement Abbott supplier quality program policies, procedures and forms

  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur

  • Assess potential new suppliers for technical, quality and manufacturing capabilities

  • Provides engineering and technical support in the selection of suppliers and evaluation, material qualification, supplier performance and receiving inspection

  • Develops acceptance criteria for materials and monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

  • Provides guidance and training to Purchasing, NPD, Manufacturing and Quality engineers in applying program requirements

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

  • Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies

  • May lead a project teams of moderate scope and acts as a mentor to lower level contributors or less experienced staff providing guidance and work direction

DESIGN CONTROLS

  • Drives improvements through analysis of manufacturing process defect data (e.g., scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development

  • Provide Process/Quality Engineering support to product development teams, helping to ensure delivery of the highest quality of new products

  • Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements

  • Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis

  • Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products as necessary

  • Assists in generating component specifications

  • Reviews new design specifications and provides input from component quality and manufacturability perspective

  • Reviews and approves all supplied product drawings and component specifications

  • Provides technical support for the introduction of components from a new supplier

SUPPLIER CONTROLS

  • Drives the development, maintenance and improvement of quality components sourced from outside suppliers

  • Lead Supplier Quality program requirements (e.g., Drive the Supplier Quality function as a functional leader)

  • Drives improvement and corrective action in the quality of components sourced from outside suppliers

  • Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation

  • Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits

  • Proactively communicates quality issues directly to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions

  • Contributes and participates in supplier performance reviews

  • Evaluates and develops Supplier Quality and Supplier Data Agreement partnerships with suppliers

MATERIAL CONTROLS

  • Generates and maintains incoming inspection procedures and trains inspectors to these procedures

  • Develops and/or sources inspection tools, equipment or systems

  • Manages development of supplied product inspection procedures, first article requirements and component qualification

  • Provides engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures

  • May direct Supplier Quality Technicians and/or receiving inspection personnel

  • Analyzes incoming material defects and works with Manufacturing engineering to assess and address purchased product issues

  • Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews

  • Dispositions and drives corrective action as necessary

  • Supports investigations of field failures related to supplier materials

Qualifications

Bachelor's degree in Engineering Mechanical, Electrical, Chemical or Industrial Engineering preferred or Master’s degree preferred. 5+ years related experience and/or training, or equivalent combination of education or experience.

  • Demonstrated supervisory experience, and detailed knowledge of FDA, GMP, ISO13485

  • Ability to work within a team or as an individual contributor in a fast paced, changing environment

  • Ability to leverage and/or engage others to accomplish projects and removes barriers impeding the progress of projects or programs

  • Experience implementing quality and/or supplier quality programs that influence change and improvements within the supply chain

  • Using a structured approach, is able to manage multiple and/or complex projects and priorities

  • Directly influences project or program direction and scope

  • 4+ years prior medical device experience preferred

  • 3+ years of Process Quality or Process Engineering experience

  • Supplier controls process knowledge and experience

  • Experience and working knowledge of FDA regulations/ISO standards for medical devices preferred

  • Six Sigma or Process Control & Monitoring (SPC) and statistical analysis packages such as JMP or Minitab

  • Experience with CAPA/SCAR, complaint investigation, field action processes and risk management (FMEA)

  • ASQ certification in Quality Engineering (CQE)

  • Six Sigma of Lean belt certification

  • Knowledge of Quality tools/methodologies, such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.)

  • Individual must have hands-on approach

  • Strong organizational and time management skills

  • Strong technical writing skills

  • Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint)

  • Experience with SAP

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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