Job Title: Supplier Quality Engineer (Medical Device Industry)
Duration : 12+ Months ( W2)
Job Description:
We are seeking an experienced Supplier Quality Engineer to support supplier quality and regulatory compliance activities in the medical device industry. In this role, you'll work closely with suppliers to ensure quality standards are met and maintained, managing quality assurance processes and supporting continuous improvement initiatives within the supply chain.
Key Responsibilities:
Supplier Quality Management : Evaluate, select, and approve suppliers to ensure they meet the company's quality standards and regulatory requirements (FDA, ISO 13485).
Process Validation : Conduct and oversee process validation activities (IQ/OQ/PQ) for supplier-provided components and materials.
Root Cause Analysis & CAPA : Lead investigations for quality issues related to supplier materials, identifying root causes and implementing corrective and preventive actions (CAPA).
Quality Audits : Conduct supplier audits and assessments, including follow-ups on corrective actions, to verify compliance with regulatory standards and quality requirements.
Documentation & Reporting : Develop, review, and maintain supplier quality documentation, including inspection reports, audit findings, and validation records.
Cross-functional Collaboration : Collaborate with internal teams (e.g., manufacturing, engineering, quality) and suppliers to resolve quality issues, improve processes, and enhance product reliability.
Regulatory Compliance : Ensure supplier quality processes align with FDA regulations, ISO 13485, and other industry standards, maintaining up-to-date knowledge of regulatory changes affecting suppliers.
Qualifications :
Education : Bachelor's degree in Engineering, Quality Management, or a related technical field.
Experience : 3+ years of supplier quality engineering experience in the medical device industry.
Technical Skills : Knowledge of quality management tools and techniques, including process validation, CAPA, risk management, and statistical analysis.
Regulatory Knowledge : Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and ISO 9001 standards.
Auditing Skills : Experience conducting supplier audits and working with suppliers on corrective actions.
Communication Skills : Strong written and verbal communication skills, with an ability to interact effectively with suppliers and internal stakeholders.
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