Quality System Engineer II

Balt USA; Irvine (CA); On-site; USD 90,000 - 100,000; Full time

Job summary

Balt USA is seeking a Quality System Engineer II to support its quality system, including coordinating NCMRs and CAPAs, audit support, and document control and training compliance. The role works with multiple functions and leadership to improve QS processes for neurovascular medical devices.

Requirements include a Bachelor’s in engineering/science, 3+ years in a related field, medical device or pharma experience, data analysis skills, and ASQ is a plus.

Qualifications

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

Responsibilities

• Knowledge of quality systems for medical device manufacturing and requirements for manufacturing, inspection and testing.
• Plans, documents (protocol and reporting) product/process validations.
• Participate in audit activities.
• Initiate and/or verifies corrective and preventative actions resulting from NCMRs, CAPAs, audit findings and customer complaints.
• May help with qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ.
• Identify, evaluate, and supports software validation activities.
• Lead meetings for process improvement and problem solving.
• Communicate with process stakeholders to address quality concerns and resolves issues.
• Maintain and develop processes and procedures by writing standard work instructions for quality system enhancements supporting production and quality controls.
• Have a clear understanding of FDA’s QMSR, ISO 13485 requirements, EU medical device regulation, and a good understanding in the application of statistics to process analysis and improvement.

Skills

Attention to detail

Technical writing

Independent worker

Cross-functional teamwork

Communication skills

Risk management

Process validation

CAPA process

Documentation

Design controls

Statistical analysis

Education

Bachelor's degree in engineering or science

Tools

Microsoft Project

Word

Excel

PowerPoint

Windows

Visio

Job description

About Balt

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

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.

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.

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.

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

Description

About this opportunity – Quality System Engineer II

The Quality System Quality Engineer II will be responsible for supporting Balt USA’s quality system including, but not limited to, coordination of NCMRs and CAPAs, supporting audit execution, and supporting document control and training compliance.

This Quality Engineer will be expected to work directly with different functions while receiving support and guidance from other engineering staff and the QS Supervisor to complete tasks.

This position will have the responsibility to support and continuously improve current QS processes through technical and process innovation for the manufacture of neurovascular medical devices.

Job Responsibilities

• Knowledge of quality systems for medical device manufacturing and requirements for manufacturing, inspection and testing.


• Plans, documents (protocol and reporting) product/process validations.


• Participate in audit activities.


• Initiate and/or verifies corrective and preventative actions resulting from NCMRs, CAPAs, audit findings and customer complaints.


• May help with qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ.


• Identify, evaluate, and supports software validation activities.


• Lead meetings for process improvement and problem solving.


• Communicate with process stakeholders to address quality concerns and resolves issues.


• Maintain and develop processes and procedures by writing standard work instructions for quality system enhancements supporting production and quality controls.


• Have a clear understanding of FDA’s QMSR, ISO 13485 requirements, EU medical device regulation, and a good understanding in the application of 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.

Skills

• Keen attention to detail when reviewing documentation and processes.


• Solid technical writing ability.


• Be able to work independently and cross functionally as part of a team.


• Comfortable communicating with a wide range of people from production, regulatory, management, suppliers, and other functions.


• General understanding of risk management, including design, use, and process FMEAs as well as a basic understanding of severity, occurrence, and risk mitigation and their impact on product and process controls.


• General understanding of process validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices.


• Understanding of CAPA process and root cause analysis tools and how to use them.


• Ability to develop manufacturing documentation (e.g., manufacturing procedures, engineering drawings, BOM, work orders).


• General familiarity with design control requirements and V&V testing for new product designs.


• Effectiveness with lab equipment, assembly tools, and measurement devices.


• Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing.


• Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.

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 periods of walking or standing

More information please go to www.baltgroup.com

Pay Range: $90,000 USD - $100,000 USD