Quality Engineer

In this critical role, you will be the champion for quality on the manufacturing floor. You will leverage your expertise to proactively identify and mitigate potential quality risks throughout the production process, ensuring our medical devices meet the highest standards.

Responsibilities

• Conduct routine inspections and audits of manufacturing processes, equipment, and materials to ensure adherence to established quality standards and procedures (e.g., ISO 13485, FDA QSR).
• Analyze production data to identify trends, root causes of defects, and implement corrective and preventive actions (CAPA) to continuously improve quality.
• Participate in the development and implementation of quality control plans for new and existing products, ensuring all specifications are met.
• Collaborate closely with manufacturing personnel to identify and address quality issues in real-time, preventing non-conforming product from reaching the market.
• Support product and process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain accurate and complete quality documentation, including inspection reports, CAPA records, and production control data.
• Stay up-to-date on relevant regulatory requirements and industry best practices for medical device manufacturing.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, or a related technical field (preferred).
• Minimum 3 years of experience in a manufacturing quality engineering role, ideally within the medical device industry.
• In-depth understanding of quality control principles and practices (e.g., Six Sigma, Lean Manufacturing) as applied to medical device manufacturing.
• Proven experience with conducting inspections, audits, and root cause analysis (RCA) of quality issues.
• Strong working knowledge of relevant quality management systems (QMS) and regulatory standards (e.g., ISO 13485, FDA QSR).
• Experience with manufacturing equipment calibration and maintenance procedures is a plus.
• Proficient in Microsoft Office Suite and familiar with quality management software (e.g., Minitab, SPC software) is preferred.
• Excellent analytical and problem-solving skills with a data-driven approach to quality improvement.
• Strong attention to detail, a proactive mindset, and a commitment to quality excellence.
• Excellent communication and collaboration skills to work effectively with cross-functional teams.