Sr. Supplier Quality Engineer - Injection Molding

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. Primary Responsibilities 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 meet 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 create 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. Independently 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. Independently authors, provides technical assessment during the review and approval of raw‑material specifications to support approval of supplier and material qualification. Takes 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. Knowledge, Skills, and Abilities Excellent writing skills, including independently writing SOPs, forms, and risk assessments. Must be a strong technical writer. Excellent presentation skills, including independently preparing, organizing and presenting information based on the audience. Knowledge of material, formulation and manufacturing process. Strong communication skills with an ability to convey ideas clearly to all levels within a cross functional team. Proficient in Microsoft Office Suite. Knowledge and proof of experience of Good Manufacturing Practice processes and procedures. Willing to work collaboratively to identify and implement a sustainable solution. Strong attention to detail and ability to analyze data using statistical software. Strong project management and organizational skills with the ability to work on multiple projects with competing deadlines. Represents Quality Assurance interests on special projects related to new material, changes of materials and supplier management. Ability to train and mentor within and outside the group. Education Minimum: Bachelor's degree in biology, chemistry, biochemistry, biomedical engineering or related field. Experience A minimum of 8 years of relatable work experience in Quality Assurance. 5-year prior experience in Supplier Management. Technical writing, trend analysis and lead projects experience is preferred. Prior experience working with an electronic document management system is required. Experience implementing changes, trend analysis and improvements is a plus. Prior experience working with SAP is a plus. Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Drives varies may or may be required to frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Pay Scale The estimated pay scale for a Senior Supplier Quality Engineer role based in San Diego, California is $116,032.70 to $145,040.30. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Equal Employment Opportunity Statement Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg #J-18808-Ljbffr Grifols