Senior Supplier Quality Engineer

Anteris Tech•Maple Grove, MN

About The Position

Anteris is a science-driven structural heart company redefining expectations through cutting-edge solutions focused on restoring native-like physiology rather than treating symptoms of structural heart disease. We are developing a new class of TAVR designed to replicate the performance of a healthy aortic valve. With offices in Minneapolis, MN (US); Geneva, Switzerland; and Brisbane and Perth, Australia, Anteris is a growing, global, and inclusive organization. The Sr Supplier Quality Engineer provides technical leadership across supplier management activities supporting the development, commercialization, and lifecycle management of an implantable medical device system. This role is a key stakeholder in ensuring robust supplier selection, qualification, and ongoing performance, while driving effective purchasing controls and supplier quality strategies aligned with regulatory and business requirements. Working cross-functionally with Engineering, Operations, Supply Chain, and external contract manufacturers and suppliers, this 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. At Anteris Technologies, you will be part of a team dedicated to improving the quality of life for patients with aortic stenosis through innovative, life-changing medical devices.

Requirements

Bachelor’s degree in Engineering, Physical Science, or a related discipline.
4+ years' experience in an engineering role with 3+ years of Supplier Quality experience within the medical device industry.
Experience supporting Class III medical devices.
Working knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and related global standards.
Strong understanding of supplier and component qualification, supplier audits, design controls, risk management, statistics, test method validation, and new product development.
Experience with product and process verification and validation.
Ability to work effectively in a cross-functional environment.
Strong organizational, communication, and technical documentation skills.
Structured, methodical approach to problem solving.
Willingness to travel approximately 15–25%.

Nice To Haves

Master’s degree in Engineering.
Advanced knowledge of statistics, DOE, and process capability analysis.
Six Sigma or equivalent analytical problem-solving experience.
Proven leadership skills in fast-paced, regulated environments.
Experience authoring documentation for regulatory agency review.
Professional certifications such as ASQ CQE or Six Sigma.

Responsibilities

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.