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Sr. Supplier Quality Engineer at Medtronic in Fort Worth, Texas

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

Position Description:
Sr. Supplier Quality Engineer in Fort Worth, TX. Assure materials supplied for Medtronic products are of high quality and reliability. Communicate technical objectives between MPSS and material suppliers. Develop and maintain inspection procedures for components and materials to support receiving inspection. Coordinate with cross-functional team in supplier selection process. Apply statistical methods for analyzing data to evaluate the current process and process changes at Supplier. Coordinate Supplier Change Requests process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Assist in initiating and maintaining Supplier Quality Agreements. Ensure compliance of suppliers through participating in supplier audits. Coordinate supplier qualification, supplier development, facilitating improvements, material evaluation and qualification & validation, disposition of non-conforming material & corrective action. Navigate the complexities of Quality Engineering in the medical device field. Coordinate CAPA's (Corrective and Preventive Action) life cycle, FMEA's and Risk Assessments of all suppliers. Implement Supplier Controls, Process Validation, Design of Experiments, Gage Repeatability & Reproducibility and Geometric Dimensioning and Tolerancing. Coordinate failure investigation techniques, statistical quality control, protocol & report preparation and non-conforming product controls. Utilize systems for Good Manufacturing Practices in medical device environment. Navigate government and industry standards which includes Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation, EU Medical Device Directive (EU MDD 93/42 EEC), JPAL and ISO 13485, ISO 17025, ISO 9001 & ISO 14971. Review development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations. Leverage knowledge of engineering through American Society for Quality Engineer certification (CQE).

Basic Qualifications:
Master's degree in Industrial, Mechanical or Biomedical Engineering or related engineering field and 2 years of experience in quality engineering. Must possess 2 years of experience with each of the following: CAPA's (Corrective and Preventive Action) life cycle, FMEA's and Risk Assessments at suppliers; Supplier Controls, Process Validation, Design of Experiments, Gage Repeatability & Reproducibility and Geometric Dimensioning and Tolerancing; Failure investigation techniques, statistical quality control, protocol & report preparation and non-conforming product controls; Good Manufacturing Practices in medical device environment; QSR 21 CFR 820), Canadian Medical Device Regulation, EU Medical Device Directive (EU MDD 93/42 EEC), JPAL and ISO 13485, ISO 9001 & ISO 14971; and Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, and Test Method Validations.