Supplier Quality Engineer

Job Title: Supplier Manufacturing EngineerDuration: 12+ Months (Possible temp to hire)Location: Maple Grove, MN 55311Hybrid RoleResponsibilities:Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product.This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Education/Experience:Bachelor’s degree in engineering is required!2-5 years of experience in a manufacturing environment.Problem solving, being able to showcase examplesManufacturing experienceValidation experienceChange management experienceAbility to travel up to 15% of the time. (Domestic possible.)Preferred qualifications:Experience working with suppliers or in supply chain management.Experience working in the Medical Device Field.Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).Excellent communication and project management skills.Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.