Senior Supplier Quality Engineer

Anteris Technologies
Any Location, MN
Job Description
The Senior Supplier Quality Engineer provides technical leadership across supplier management activities supporting the development, commercialization, and lifecycle management of an implantable medical device system. The role ensures supplier quality systems, component quality, and regulatory compliance are established and sustained. The Supplier Quality Engineer will define and execute technical purchasing control requirements through consultation, critical review, and hands-on ownership of supplier quality deliverables.

Requirements

  • Own supplier and component qualification processes, including initial approval and lifecycle management.
  • Lead supplier management activities, including audits, performance scorecards, corrective actions, and change management.
  • Drive investigation, permanent resolution, and prevention of supplied component nonconformances.
  • Maintain and manage the Approved Supplier List (ASL).
  • Review and influence component specifications to improve quality, manufacturability, and supplier capability.
  • Lead supplier and supplied component change notification and assessment processes.
  • Develop and manage supplied product inspection strategies, including first article inspection (FAI).
  • Provide technical guidance to Receiving Inspection, including statistical analysis, measurement methods, and Gage R&R; apply expertise in metrology and optical measurement systems.
  • Assess supplier capabilities through on-site visits, technical reviews, and directed testing.
  • Partner with suppliers to define and execute process validation strategies.
  • Proactively communicate quality issues through data-driven supplier corrective action requests and technical discussions.
  • Drive continuous improvement of externally sourced component quality.
  • Own performance evaluation and oversight of contract manufacturers.
  • Develop and assess control plans, skip-lot programs, dock-to-stock strategies, and CoC/CoA frameworks.
  • Apply engineering judgment and data analysis to reduce reliance on inspection where appropriate.
  • Collaborate with cross-functional teams to resolve supplied component quality issues.
  • Apply structured problem-solving methodologies (e.g., DMAIC) to identify, prioritize, and resolve quality risks.
  • Represent Supplier Quality as a core team member on cross-functional initiatives.
  • Partner with suppliers to document Process Flow Diagrams, PFMEAs, and Control Plans to mitigate risk.
  • Support internal and external audits, including preparation and direct interaction with auditors.
  • Ensure compliance with FDA regulations, global regulatory requirements, company policies, and procedures.
  • Maintain effective working relationships across all levels of the organization and external partners.
  • Perform other related duties as assigned.

Benefits

  • Medical, Dental, and Vision Plans
  • Flexible Spending Account (FSA)
  • 401k + Company Match
  • Life, AD&D, Short Term and Long-Term Disability Insurance
  • Bonus Plan Eligibility
  • Employee Equity Program
  • Paid Holidays & PTO
  • Employee Assistance Program
]]>