Quality Systems Engineer II — Medical Devices

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

Job summary

Balt Brasil is seeking a Quality System Engineer II to support its quality system, coordinating NCMRs and CAPAs while enhancing processes for neurovascular medical devices. This role demands a Bachelor’s degree along with at least 3 years of engineering experience.

The ideal candidate will have a solid understanding of FDA regulations and ISO standards, with strong communication skills to interact with multiple departments. Join us and make a difference in medical technology.

Qualifications

• 3+ years of experience in engineering in a related field.
• Prior medical device or pharmaceutical experience is preferred.
• ASQ certification is a plus.

Responsibilities

• Support Balt USA's quality systems including NCMRs and CAPAs.
• Plan and document product/process validations.
• Lead meetings for process improvement.

Skills

Attention to detail

Data analysis

Technical writing

Communication skills

Education

Bachelor’s degree in engineering or science

Tools

Microsoft Project

Microsoft Word

Microsoft Excel

Statistical analysis tools

Job description

Balt Brasil is seeking a Quality System Engineer II to support its quality system, coordinating NCMRs and CAPAs while enhancing processes for neurovascular medical devices. This role demands a Bachelor’s degree along with at least 3 years of engineering experience.

The ideal candidate will have a solid understanding of FDA regulations and ISO standards, with strong communication skills to interact with multiple departments. Join us and make a difference in medical technology.