Grifols · 2 months ago
Sr. Supplier Quality Engineer - Injection Molding
SD Metro Area
Full-time
Onsite
Senior Level, Lead/Staff
$116K/yr - $145K/yr
8+ years expGrifols is a global healthcare company that has been working to improve health and well-being since 1909. They are seeking a Senior Supplier Quality Engineer who will serve as a primary quality lead on cross-functional teams, focusing on new materials, supplier qualification, and ensuring compliance with quality standards and regulations.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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
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
Ability to train and mentor within and outside the group
Preferred
Technical writing, trend analysis and lead projects experience
Prior experience working with an electronic document management system
Experience implementing changes, trend analysis and improvements
Prior experience working with SAP
Benefits
Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase