Supplier Quality Engineer II

Anteris Technologies•Maple Grove, MN

4d•$100,000 - $120,000

About The Position

The Supplier Quality Engineer II provides technical supplier management leadership supporting the development, commercialization, and on-going supplier relationships to support an implantable medical device system. This position will be a key stakeholder to ensure robustness in supplier selection, supplier qualification, component qualification, supplier corrective actions and participate in the development of various supply chain strategies. 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 related discipline.
5+ years' Supplier Quality experience in a medical device company
Minimum of 5 years’ experience executing New Product Development, Design Controls, and/or developing Design Control Processes in accordance with CFR 820.30 (FDA QSR) and/or ISO 13485.
Experience working with class III medical devices.
Working knowledge of ISO 13485, 14971 and FDA CFR 820 and similar global standards.
Thorough understanding of design controls, risk management, statistics, test method validation, and new product development processes.
Knowledge of product and process verification and validation.
Ability to work as part of a cross functional team.
Ability to define, organize, and manage individual and team tasks.
Effective verbal and written communication.
Proficient in technical report writing and review.
Structured and methodical problem-solving approach.
Foster a positive culture of growth, collaboration, and achievement across the organization.
Ability to travel approximately 15%

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.
Experience authoring documentation for regulatory agency review.
Professional certifications such as ASQ CQE or Six Sigma

Responsibilities

Execute the supplier and component qualification processes.
Lead the supplier management activities, including supplier audits, scorecards, corrective action and change management.
Lead the investigation, permanent resolution, and prevention of supplier component nonconformances.
Review component specifications and proposes changes to existing specifications to support component quality and manufacturability.
Manage development of supplied product inspection procedures, internally and at suppliers, and first article requirements.
Provide engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, and Gage R&R studies.
Assess supplier capabilities through direct visits, technical discussions, and directed testing.
Collaborate with suppliers to develop comprehensive process validation strategies.
Proactively communicate quality issues to suppliers as needed through supplier corrective action requests, data driven and technical discussions.
Drive the development, maintenance, and improvement of quality of components sourced from outside suppliers.
Responsible for contract manufacture’s performance and evaluation.
Evaluate and develop control plans, skip lot, dock-to-stock, CoC, and CoA partnerships with suppliers.
Apply thorough engineering analysis and judgement to reduce the need for inspection in accordance to program policies and data gathered.
Work with Manufacturing Engineering to assess and address supplied component issues.
Responsible for Supplier Quality activities such as: Supplier Audits, Supplier performance, etc.
Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Participate in or lead teams in supporting Supplier Quality program requirements (e.g., represent the Supplier Quality function as a Core Team Member).
Mitigate risk by work in partnership with the suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
Support internal and external audits – including preparation and direct interaction with auditors.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities, on occasion, as assigned.