Sr. Supplier Quality Engineer - Injection Molding

GRIFOLS, S.A.•San Diego, CA

44d•$116,033 - $145,040•Onsite

About The Position

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.

Requirements

Minimum: Bachelor's degree in biology, chemistry, biochemistry, biomedical engineering or related field
A minimum of 8 years of relatable work experience in Quality Assurance.
5-year prior experience in Supplier Management.
Experience in injection molding and plastics (direct expertise, maintenance, quality).
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.
Prior experience working with an electronic document management system is required.

Nice To Haves

Technical writing, trend analysis and lead projects experience is preferred
Experience implementing changes, trend analysis and improvements is a plus.
Prior experience working with SAP is a plus.
Ability to train and mentor within and outside the group.

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 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.
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 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.