Senior Supplier Quality Systems Analyst (On-Site or Hybrid Remote)

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Posted 2 days ago United States Salary undisclosed
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Job Description

Position Overview: This role will be part of our Corporate Supplier Quality team located in Irvine, CA while partnering globally with our external suppliers and internal Supplier Quality teams across all business units, manufacturing sites, and regional offices within Edwards. The Senior Supplier Quality Analyst will be responsible for overseeing our Quality Management System (QMS) software databases for Supplier Management and Purchasing Controls. This role will report metrics from the database, support database changes, as well as develop user training materials for the databases. Job Functions / Key Responsibilities: Provide subject matter expertise on Quality Management Systems (QMS) databases for Supplier Management and Purchasing Controls. Identify and recommend opportunities for improvement related to current business processes and systems for Supplier Management and Purchasing Controls. Provide first-level help desk support to users, including process coaching and troubleshooting system issues, (e.g., system access, systems response) before escalating to IT if needed. Administrate system workflows and provide feedback to originators. Workflows may include: supplier system change tickets (SARs), supplier notification of changes (NOCs), supplier corrective action requests (SCARs), product lifecycle management engineering change requests (ECRs), and corrective action preventive actions (CAPA). Collect and generate metrics for reporting to upper management on process & supplier performance. Receive and provide input to procedures, instructions, system step guides, and forms. Develop end user training programs. Additional responsibilities as assigned by management. Minimum Required Education & Qualifications (Must Have): Bachelor's Degree plus a minimum of five (5) years of experience in Supplier Quality, Quality Engineering/Assurance, Quality Systems, and/or Data Systems; OR Master's Degree with a minimum of three (3) years of experience Highly regulated industry experience (i.e. Medical Device, Pharmaceuticals, Aerospace, or Automotive, etc) Preferred Qualifications (Nice To Have): Medical Device industry experience Quality Management Systems (QMS) experience Data management experience Experience managing or owning CAPAs and Non-Conformances Experience with Enterprise level information systems such as Qlikview, ERP (JDE, SAP, etc), PLM (TeamCenter, Agile, etc), QMS (ETQ Reliance, Pilgrim, TrackWise, Master Control, etc) In-depth understanding of medical devices regulations (e.g., FDA 21 CFR Part 820 and ISO 13485) Advanced computer skills in MS Office Suite Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.