Quality Engineer

Job Title

Job Description Required Education: Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or related field. Required Qualifications: Minimum 1 year of Quality Engineering or Manufacturing Engineering experience. Knowledge of Change Management and Quality Management Systems (QMS). Strong analytical, troubleshooting, and problem-solving skills. Excellent written and verbal communication skills. Strong organizational skills with exceptional attention to detail. Proficiency in Microsoft Office (Excel, Word, and PowerPoint). Ability to manage multiple priorities in a fast-paced manufacturing environment. Ability to work independently while collaborating effectively with cross-functional teams. Up to 10% travel as required.

Preferred Qualifications: Experience in the medical device industry. Working knowledge of ISO 13485, GMP (Good Manufacturing Practices), GDP (Good Documentation Practices). Experience supporting Product Transfers, Supplier Change Requests, PPAP, Process Validation (IQ/OQ/PQ), First Article Inspection (FAI), Risk Management, Statistical analysis and process capability. Familiarity with CAPA, nonconformance investigations, and continuous improvement methodologies.

Job Summary: Support quality assurance, quality control, and continuous improvement activities within a medical device manufacturing environment. Ensure products meet quality, regulatory, and customer requirements throughout the manufacturing process. Lead and support Product Transfers, Supplier Change Requests, PPAP, First Article Inspection (FAI), and validation projects. Develop, implement, and maintain quality processes, inspection methods, and manufacturing controls. Create and update Standard Operating Procedures (SOPs) and inspection plans through the change management system. Collaborate with Engineering, Manufacturing, Supply Chain, and Operations to resolve quality issues and improve processes. Serve as the quality representative on cross-functional projects, ensuring compliance with Quality Management System (QMS) requirements. Support compliance with ISO 13485, GMP, GDP, and other applicable regulatory standards. Investigate quality issues, perform root cause analysis, and drive corrective and preventive actions (CAPA). Promote continuous improvement initiatives that enhance product quality, manufacturing efficiency, and customer satisfaction. Work independently while exercising sound engineering judgment and professional decision-making. Build strong cross-functional relationships and serve as the voice of Quality across the organization.

**Only those lawfully authorized to work in the designated country associated with the position will be considered.**

**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**