Quality Engineer II
Job Summary:
A Quality Engineer II is responsible for leading and managing root cause investigations, ensuring timely and effective corrective and preventive actions (CAPA). This includes conducting internal audits, supporting validation activities, and providing quality support for manufacturing operations.
Key Responsibilities:
* Lead and manage root cause investigations, ensuring timely and effective CAPA.
* Manage day-to-day operations of the Quality Management System (QMS), ensuring compliance with ISO 13485 and regulatory requirements.
* Conduct internal audits to ensure continuous improvement and adherence to quality standards.
* Support and oversee validation activities, including process validation, test method validation, and risk assessments.
* Provide quality support for manufacturing operations, ensuring product compliance, process control, and efficiency.
* Develop and implement Standard Operating Procedures (SOPs) and work instructions to support quality initiatives.
* Serve as primary quality contact for customer quality concerns, complaints, and regulatory inquiries.
Requirements:
* Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline.
* 3+ years of experience in medical device or regulated manufacturing environment.
* Strong expertise in root cause analysis, CAPA management, and failure investigations.
* ISO 13485 lead auditor training (certification preferred but not required).
* Proven experience in internal auditing and regulatory compliance.
* Strong knowledge of quality engineering principles, including FMEA, SPC, risk management, and validation processes.