Supplier Quality Engineer

Job Title:

Supplier Quality Engineer Job Description

• Support site inspection readiness activities to ensure the facility and quality systems remain compliant with FDA, EMA, and other cGMP regulatory requirements, as well as client expectations.
• Oversee and coordinate material movements to ensure that incoming materials and components meet defined quality and regulatory standards.
• Participate in and support client audits and regulatory inspections, including preparation, facilitation, and follow‑up on audit findings and commitments.
• Work closely with suppliers to resolve supplier quality issues, including investigating nonconformances and implementing effective corrective and preventive actions.
• Manage supplier‑initiated change controls by assessing impact, coordinating internal reviews, and ensuring appropriate approvals and documentation.
• Lead or support risk assessments related to supplier materials, processes, and changes, using formal risk management tools and methodologies.
• Administer and manage Supplier Corrective Action Requests (SCARs), ensuring timely investigation, root cause analysis, corrective action implementation, and effectiveness verification.
• Implement and maintain quality initiatives that enhance supplier performance, product quality, and regulatory compliance.
• Support and enhance quality systems, including CAPA, deviation management, change control, risk management, and document control.
• Conduct or support internal and external quality audits of suppliers and internal processes, documenting findings and driving closure of actions.
• Oversee or support validation and qualification activities related to supplier materials, processes, and equipment, ensuring adherence to protocols and regulatory expectations.
• Utilize electronic Quality and Training Management Systems to manage documentation, training, deviations, change controls, and related quality records.
• Apply advanced problem‑solving and root cause analysis tools to address quality issues and drive continuous improvement.
• Collaborate with cross‑functional teams, including manufacturing, engineering, procurement, regulatory, and quality control, to align on quality requirements and resolve issues.
• Prepare, review, and maintain quality documentation, including procedures, reports, and records, to support a robust quality management system.
• Use statistical analysis and quality tools to monitor supplier performance, analyze trends, and propose data‑driven improvements.
• Manage multiple projects and priorities, ensuring timely completion of quality‑related tasks and initiatives.
• Communicate effectively with internal stakeholders, suppliers, and external customers or regulators to convey quality expectations, findings, and resolutions.
• Travel up to approximately 25% of the time, as needed, to support supplier audits, assessments, and quality‑related activities.

• 7–10 years of experience in Quality Assurance with a BS degree in a STEM field, or an advanced degree plus at least 3 years of experience, or a bachelor’s degree plus at least 5 years of experience in quality assurance within a regulated industry.
• Background in pharmaceutical or medical device industries, with a strong preference for pharmaceutical experience; experience in a GMP or regulated environment is required.
• Strong knowledge of cGMP and applicable regulatory requirements, including FDA, EMA, and other relevant guidelines.
• Hands‑on experience with quality management systems, including change control, root cause analysis, deviation management, documentation management, and training systems.
• Experience using electronic Quality and Training Management Systems to manage quality records and training compliance.
• Demonstrated expertise in CAPA and deviation management, including investigation, corrective action planning, and effectiveness verification.
• Proficiency in change control processes, including impact assessment and implementation oversight.
• Experience in risk management and FMEA methodologies for evaluating and mitigating quality risks.
• Strong skills in document control, including authoring, reviewing, and maintaining controlled documents.
• Experience…