As a Quality Engineer for a manufacturer of medical devices, you will play a key role in ensuring the compliance, reliability, and performance of products.

Key Responsibilities

• Quality Systems Management
• Conduct internal audits to ensure adherence to quality procedures
• Develop and validate manufacturing processes
• Working knowledge of PPAP activities (correlation studies, GR&R, Capability, etc…)
• Complaint handling to investigate and resolve quality issues, implementing root cause analysis and corrective/preventive actions (CAPA).
• Collaborate with regulatory teams to ensure product compliance with applicable FDA and international medical device regulations.
• Evaluate and qualify suppliers
• Interface with customers to address quality-related issues
• Prepare and maintain quality documentation, including standard operating procedures (SOPs), work instructions, and inspection records.
• Analyze quality data, generate reports, and recommend improvements 
• Train and mentor staff on quality standards and best practices.