Anteris Technologies · 22 hours ago
Senior Supplier Quality Engineer
Maple Grove, MN
Full-time
Onsite
Mid, Senior Level
4+ years expAnteris Technologies is a science-driven structural heart company focused on innovative solutions for structural heart disease. The Senior Supplier Quality Engineer will provide technical leadership in supplier management activities, ensuring robust supplier selection and ongoing performance while maintaining compliance with regulatory requirements.
BiotechnologyHealth CareMedical
No H1B
Hiring Manager
Erica Almgren Steffenson
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
Qualification
Required
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%
Currently, Anteris is unable to sponsor or transfer employment visas for this position
Preferred
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
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
Inclusive Team Environment
Company
Anteris Technologies
Anteris Technologies is a structural heart company focused on developing innovative & durable health solutions.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$234.29MKey Investors
Partners for Growth
2026-01-22Post Ipo Equity· $200M
2023-02-09Post Ipo Equity· $24.29M
2017-10-01Post Ipo Debt· $10M
Leadership Team
Wayne Paterson
CEO and Managing Director
David St. Denis
Chief Operating Officer
Recent News
2026-01-22
Company data provided by crunchbase