Sr. Supplier Quality Engineer - Injection Molding

Overview

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions in San Diego, CA is seeking a Senior Supplier Quality Engineer. The Sr Supplier Quality Engineer will function as a primary quality lead on cross-functional teams focusing on new materials, suppliers’ qualification, and supplier changes. This position will be responsible for development and updates of material specifications and ensure that correct and appropriate specifications have been created and approved.

The Sr Supplier Quality Engineer will ensure that correct and appropriate internal and external requirements, standards, and regulations are applied in the Quality Management System.

To be successful in this position, we are seeking individuals with at least a minimum Bachelor  degree in biology, chemistry, biochemistry, biomedical engineering or related field. Along with a minimum of 8 years of relatable work experience in Quality Assurance and 5-year prior experience in Supplier Management. For this role, we are seeking individuals with experience in injection molding and plastics (direct expertise, maintenance, quality).

Primary responsibilities for role:

• Applies risk-based approach for creation and execution of the annual supplier audit program, providing guidance to the team for the successful completion.
• Develops and executes qualification program for new materials and suppliers using risk-based approach. Defines and monitors supplier risk-level by evaluating material using the supplier risk-tool and ensures that the supplier and material meets Grifols requirements.
• Provides rationale for the supplier status event report and ensures the appropriate actions were addressed and are timely completed.
• Ensures the appropriate Vendor Notification process is established and the communication of nonconformances (SCAR) to suppliers is maintained, ensures that property investigation is conducted, root cause is analyzed, and corrective plans are appropriated and assigned, working internally with cross-functional Grifols teams and external Suppliers. Provides technical assessment on the effectiveness of resolutions of Supplier issues.
• Lead internal investigations to appropriately define root-cause of Low, Medium and High-risk material and supplier related issues. Applies appropriate statistical methods to effectively creates the corrective and preventive plans. Ensures on-time and appropriate closure of supplier actions (SCAR).
• Reviews, approves and monitors the Supplier Qualification and Performance (scorecard). Ensures all follow-up action items are timely completed.
• Collaborates with Grifols suppliers to provide technical assessment and approval on the required suppliers quality documentation, such as Questionnaires, and approves plans for improvement.
• Develops and trends Supplier Quality System metric to identify opportunities for improvements
• Creates, reviews and approves supplier quality procedures, providing feedback, improvements and implement action items on the Supplier Quality Management System procedures and documentation to ensure compliance with Grifols and external requirements and regulations
• Assesses the quality agreements between Grifols suppliers in a timely manner for approval of supplier qualification.
• Independent conducts and approves external and/or internal audits. Approves audit report and, ensures final audit report and any associated nonconformances to the supplier are accordingly completed, as applicable
• Independent authors, provides technical assessment during the review and approval of raw-material specifications to support approval of supplier and material qualification
• Takes the ownership of critical issues, leads and stakeholder meetings, writes minutes and follows up on action items and summarizes conclusions and provides technical assessment on supplier related change control processes and monitors change implementation.
• Writes and approves technical assessments on supplier change notifications. Serves as a Subject Matter Expert in supporting the assessment and approval of Supplier change notifications, assessing the impact on the product quality and Quality Management System.
• Provides Technical assessment for the development of new employee quality system or procedural training and develop department training programs, as needed
• Hosts 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business.

• Excellent writing skills, including independently writing SOPs, forms, and risk assessments. Must be a strong technical writer.
• Excellent…