Supplier Quality Engineer

Job Title:

Supplier Quality Engineer

Job Description

The Supplier Quality Engineer plays a key role in ensuring quality excellence and regulatory compliance across manufacturing operations. In this position, you support site inspection readiness, material movements, client audits, and supplier quality and material compliance activities. You collaborate closely with suppliers and internal stakeholders to ensure products meet the highest standards while contributing to a culture of continuous improvement and compliance.

This role directly supports the mission of enabling customers to make the world healthier, cleaner, and safer.

Responsibilities

+ Support site inspection readiness activities to ensure ongoing compliance with FDA, EMA, and other cGMP regulations, as well as client-specific requirements.

+ Oversee and support material movements to ensure that incoming materials and components meet established quality and regulatory requirements.

+ Participate in and support client audits, regulatory inspections, and internal audits by providing documentation, responses, and subject matter expertise related to supplier quality and quality systems.

+ Work directly with suppliers to resolve supplier quality issues, including investigation, root cause analysis, and implementation of corrective and preventive actions.

+ Manage and track Supplier Corrective Action Requests (SCARs), ensuring timely closure, effectiveness verification, and appropriate documentation.

+ Review and oversee supplier-initiated change controls, assessing impact on product quality, regulatory compliance, and supply continuity.

+ Conduct and support risk assessments, including use of tools such as FMEA, to identify, evaluate, and mitigate risks associated with suppliers, materials, and processes.

+ Implement, maintain, and improve supplier quality management processes in alignment with corporate quality policies and regulatory expectations.

+ Ensure effective use of quality systems, including change control, deviation and CAPA management, document control, and training systems, to maintain a robust quality management system.

+ Support validation and qualification activities related to suppliers, materials, and processes, ensuring adherence to validation and qualification protocols.

+ Contribute to process improvement initiatives that enhance quality, efficiency, and compliance across the supply base and internal operations.

+ Prepare, review, and maintain quality documentation, including procedures, specifications, audit reports, and risk assessments, ensuring accuracy and regulatory compliance.

+ Collaborate with cross-functional teams such as manufacturing, engineering, regulatory, and procurement to align on quality expectations and resolve issues.

+ Communicate effectively with internal teams, external suppliers, and regulators to provide clear updates, reports, and recommendations on supplier quality performance.

+ Use statistical analysis and quality tools to monitor supplier performance, identify trends, and drive data-based decision making.

+ Manage multiple projects and priorities simultaneously, ensuring timely completion of quality-related activities and deliverables.

+ Support a culture of continuous improvement by identifying opportunities to strengthen quality systems, processes, and supplier relationships.

+ Travel up to approximately 25% as needed for supplier visits, audits, and cross-site collaboration.

Essential Skills

+ 7-10 years of experience in Quality Assurance with a Bachelor's degree in a STEM field, or an advanced degree with at least 3 years of experience, or a Bachelor's degree with at least 5 years of experience in quality assurance within a regulated industry.

+ Experience in pharmaceutical, medical device, or biotech industries, with a preference for pharmaceutical experience.

+ Experience working in a GMP or other regulated environment.

+ Strong knowledge of cGMP and applicable regulatory requirements, including FDA and EMA expectations.

+ Hands-on experience with quality systems, including change control, root cause analysis, deviations, documentation management, and training systems.

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Experience with electronic…