Quality Engineer I

About Balt  

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

 Our story 

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. 

 Why Join Balt? Join a passionate team, dedicated to making a difference.  

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

Would you like to be part of our story? Don't hesitate, come and join us! 

 About this opportunity – Quality Engineer I

Description

This position is responsible for the implementation, maintenances, and sustainment of the Balt USA’s quality management system in accordance with procedures compliant with 21 CFR Part 820 and ISO 13485 requirements. Develops and analyzes quality systems procedures and documents by leveraging regulatory requirements and continuous improvement principles.

Upholds compliance efforts for NCMR, CAPA, quality audits, procedure adherence, GMP enforcements and applies continuous improvement principles to support kaizen events, problem solving, fixturing improvement, and scrap reduction. Support efforts for supplier quality management and supplier development as part of nonconforming corrective action. 

Works with various employees to develop, improve, and stabilize quality process controls. Monitors quality issues to help determine root cause and implement corrective action. Works with all functions to achieve quality and business goals. Compiles and writes training material and conducts training sessions on quality control activities.

Must be able to the work the hours required to fulfill operational demands.

 Job Responsibilities

• Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions.
• Completes QE disposition for RGA, NCMR, and CAPA.
• Manages processing of internal NCMRs and/or complaints and participate in MRB and/or complaint review sessions.
• Communicates with suppliers to address quality concerns and resolves issues
• Conduct product investigation from product complaint returns and complete documentation using standard complaint handling system.
• Fulfills document control and records requirements, such as completion of design and validation reports, and initiating change orders.
• Maintains and develops processes and procedures by writing standard work instructions for operations involved with production and quality.
• Maintains confidential company and supplier information.
• Works with production operators and QC inspectors in the production environment, as required.
• Provide feedback to Quality, Operations, Engineering and R&D on quality issues.

 

Qualification Requirements

• Bachelor’s degree required, preferably in engineering or science discipline.
• 0-2 years in quality assurance for medical device manufacturing.
• Knowledge of ISO 13485 and medical device regulation, 21 CFR Part 820, and other international standards and regulations.
• Knowledge of quality requirements for medical device manufacturing and requirements for inspection and testing.
• Familiar with quality tools such as risk management and statistical techniques.
• Use of Microsoft programs including Word, Excel, and PowerPoint.
  • Fundamental use of spreadsheet and statistical analysis skill set.

 

Skills

• Inspection techniques, including technical documentation and mechanical drawings.
• Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing.
• Plans, documents (protocol and reporting) product/process validations.
• Participate in supplier qualification activities and audits.
• Initiates and/or verifies corrective and preventative actions resulting from NCMRs, audit findings and customer complaints.
• Develops and completes qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ, etc.
• Identify/evaluate quality inspection/test equipment requirements.

 

Work Environment

• Working conditions are normal for an office environment.
• Extended computer usage.
• Standard PPE gowning requirement for cleanroom activities is required.
• Moderate lifting.
• Extended microscope, visual measuring system, and computer usage.
• Extended periods of walking or standing.

 

Balt Group is an Equal Employment Opportunity employer.

 

More information please go to www.baltgroup.com 

 

 

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.

 

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