Supplier Quality Engineer

Overview:

This role is responsible for providing quality engineering leadership and support to partner with suppliers and contract manufacturing organizations to deliver materials, components, subassemblies and services that comply with Breathe Technologies specifications, regulatory agency expectations and customer/patient needs. Communicate, manage and resolve supplier related challenges to ensure the company successfully meets product delivery schedules and customer commitments.  As a critical member of the quality team, this position will collaborate with the supply chain organization to develop, manage and maintain relationships between Breathe Technologies and supplier and contract manufacturing organizations.

 Essential Responsibilities:

  • Collaborate with product design and development engineering, regulatory, clinical and manufacturing operations to ensure appropriate quality requirements are clearly defined and satisfy target patient populations

  • Lead cross functional teams to review and evaluate impact of proposed supplier changes

  • Provide support to complaint management and post market surveillance activities by completing robust and timely complaint investigations related to material, components, sub-assemblies and services provided by suppliers and contract manufacturing organizations

  • Identify opportunities to implement supplier changes to improve system and/or process reliability, reduce scrap rates and improve yields and efficiencies

  • Manage the supplier qualification process and Approved Supplier List

  • Maintain supplier audit schedule and conduct supplier audits, where required

  • Lead the Material Review Board process and manage all Supplier Corrective Action Requests

  • Develop and implement supplier related quality indicators to support Management Review process

  • Analyze supplier quality performance indicator data and investigate adverse trends to identify variables that may potentially affect product and processes

  • Establish Quality Agreements for critical suppliers and contract manufacturing organizations related to raw materials, components, sub-assemblies and services

  • Support internal audit program for quality system elements not related to Supplier Controls

  • Collaborate with supply chain to develop, implement and maintain supplier control responsibilities

  • Supplier site visits as appropriate, nationally and internationally

Education/Experience:

REQUIRED EDUCATION:

  • BS Degree in Mechanical, Electrical or Biomedical Engineering

REQUIRED QUALIFICATIONS:

  • 5+ years engineering experience

  • 3+ years Class II or Class III medical device experience

  • Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices

  • Self-starter that can troubleshoot manufacturing processes and quickly identify solutions in fast-paced environment

  • Expertise related to Injection Molding, Mold/Tool Qualification, First Article Inspection, Process Validation and Process Controls

  • Strong organizational skills and ability to prioritize workflow to meet challenging deadlines

  • Ability to manage multiple projects and consistently resolve issues as an individual contributor as well as a key cross-functional team member

  • Ability to travel, including internationally

 DESIRED QUALIFICATIONS:

  • ASQ Certification (Certified Quality Engineer, Certified Quality Manager)

  • Experience with electro-mechanical devices including electrical safety testing

  • Demonstrated ability to act as Subject Matter Expert related to Supplier Controls, Process Validation, Process Controls and Statistical Methods

  • Experience supporting regulatory agency inspections and Notified Body Audits in an SME role

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