Sr. Supplier Quality Engineer - Injection Molding

Sr. Supplier Quality Engineer - Injection Molding

Location:

CA-San Diego, US

Contract Type:
Regular Full-Time

Area: TECHNICAL

Grifols Diagnostic Solutions in San Diego, CA is seeking a Senior Supplier Quality Engineer to lead quality initiatives on cross‑functional teams focused on new materials, supplier qualification, and supplier changes. The role is responsible for developing and updating material specifications, ensuring compliance with internal and external requirements, and supporting the Quality Management System.

Primary responsibilities:

• Apply a risk‑based approach for the annual supplier audit program and guide the team through successful completion.
• Develop and execute qualification programs for new materials and suppliers, defining and monitoring supplier risk levels using the supplier risk‑tool.
• Provide rationale for supplier status event reports and ensure timely completion of corrective actions.
• Establish a Vendor Notification process to communicate nonconformances (SCAR) to suppliers, conduct investigations, analyze root causes, and assign corrective plans.
• Lead internal investigations to define root causes of material and supplier issues, applying statistical methods to create corrective and preventive plans and ensuring on‑time closure of SCARs.
• Review, approve, and monitor the Supplier Qualification and Performance scorecard, ensuring follow‑up actions are completed.
• Collaborate with suppliers to assess and approve required quality documentation, such as questionnaires, and approve improvement plans.
• Develop and trend Supplier Quality System metrics to identify improvement opportunities.
• Create, review, and approve supplier quality procedures, providing feedback and implementing action items to ensure compliance with Grifols and external regulations.
• Assess quality agreements with suppliers for timely approval of supplier qualification.
• Conduct and approve external or internal audits, ensuring final audit reports and nonconformances are completed.
• Author and assess raw‑material specifications to support supplier and material qualification.
• Own critical issues, lead stakeholder meetings, record minutes, and follow up on action items to monitor change implementation.
• Write and approve technical assessments on supplier change notifications, serving as subject‑matter expert for quality impact.
• Provide technical assessments for new employee quality system or procedural training and develop department training programs as needed.
• Host third‑party audits from regulatory bodies, including FDA and notified bodies.

Knowledge, Skills, and Abilities:

• Excellent writing skills; ability to independently write SOPs, forms, and risk assessments.
• Strong presentation skills, capable of preparing and delivering information to various audiences.
• Knowledge of material formulation and manufacturing processes.
• Effective communication skills to convey ideas clearly across all levels.
• Proficiency in Microsoft Office Suite.
• Experience with Good Manufacturing Practice processes and procedures.
• Collaborative mindset to implement sustainable solutions.
• Strong attention to detail and ability to analyze data using statistical software.
• Organizational skills, managing multiple projects with competing deadlines.
• Representation of Quality Assurance interests on projects related to new materials and supplier management.
• Capability to train and mentor within and outside the group.

Education

Minimum:
Bachelor’s degree in biology, chemistry, biochemistry, biomedical engineering, or related field.

Experience

• Minimum of 8 years of relevant Quality Assurance experience.
• Minimum of 5 years of prior Supplier Management experience.
• Preferred experience in technical writing, trend analysis, and leading projects.
• Required experience with…