Quality System Engineer II

About the role

The Quality System Quality Engineer II will support Balt USA’s quality system, including coordination of NCMRs and CAPAs, supporting audit execution, and document control and training compliance.

This Quality Engineer will work directly with different functions while receiving support and guidance from other engineering staff and the QS Supervisor to complete tasks. This position will also support and continuously improve current QS processes through technical and process innovation for the manufacture of neurovascular medical devices.

Job Responsibilities

• Supports coordination of NCMRs and CAPAs
• Serves as a point of contact for audit execution
• Initiates and/or verifies corrective and preventative actions resulting from NCMRs, CAPAs, audit findings, and customer complaints
• Assists with qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ
• Supports software validation activities
• Leads meetings for process improvement and problem solving
• Communicates with process stakeholders to address quality concerns and resolve issues
• Maintains and develops processes and procedures by writing standard work instructions for quality system enhancements supporting production and quality controls
• Ensures a clear understanding of FDA’s QMSR, ISO 13485 requirements, EU medical device regulation, and applies statistics to process analysis and improvement

Qualification Requirements

• Bachelor’s degree required, preferably in an engineering or science discipline
• 3+ years as an Engineer in a related field
• Medical device or pharmaceutical experience
• Data analysis skill set
• ASQ certification a plus

Highly Desired Qualifications

• Class II and III implantable medical device experience with focus on neurovascular devices
• Strong communication skills working with multiple departments
• A demonstrated ability to plan and run projects