Quality Engineer II

Quality Engineer II

Apply for the Quality Engineer II role at Balt.

Our purpose is to improve the lives of 150,000 patients in 2026.

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way – collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. We introduced one of the first neurovascular intervention devices in 1977 and now offer the world’s broadest portfolio of medical devices for stroke.

As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

• Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
• No matter the country, we take care of you.

The Operations Quality Engineer II will be responsible for supporting production quality, the transfer of neurovascular products to the production environment, and supplier quality activities. This engineer will be expected to work directly with production and suppliers while being provided moderate levels of support/guidance from other engineers and their manager to complete tasks. This position will have the responsibility to support and continuously improve current manufacturing and supplier quality processes through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Daily tasks

• Production support of existing products/processes and sustaining work
• Support the manufacturing organization to facilitate efficient operations, optimize existing processes, and ensure that production goals are met.
• Develop process and procedure updates for increased efficiency, quality, and productivity.
• Work with Manufacturing Engineering to correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues.
• Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions.
• Own NCMR and CAPA investigations and corrections/corrective actions
• Support requests for new supplier onboarding and offboarding
• Complete tasks related to supplier changes and management of existing suppliers
• Spend significant portions of time in the production environment.
• Work closely with production operators and Quality Control inspectors in the production environment.
• Provide feedback to Quality, Operations, Engineering and R&D on quality issues.
• Detail oriented review and approval documentation in support of production and process improvement

Additional Tasks

• Development project work – design transfer, commercialization of new products, and site manufacturing transfers
• Interface with New Product Development team in design control projects to integrate new products or processes into the existing manufacturing area.
• Process development, validation and verification work is required – knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation/gage R&R, a clear understanding of FDA’s QMSR and cGMP, and a good understanding in the application of statistics to process analysis and improvement.
• Communicate with suppliers to address quality concerns and resolves issues.
• Maintain and develop processes and procedures by writing standard work instructions for operations involved with production and quality.

• Bachelor’s degree required, preferably in engineering or science discipline.
• 2+ years as an Engineer in a related field.
• Medical device or pharmaceutical experience.
• Process and Equipment qualification knowledge.
• Statistical analysis skill set.