Quality Engineer II (Medical Devices)

TL;DR

Quality Engineer II (Medical Devices): Developing and implementing quality system elements for new and existing catheter products with an accent on regulatory compliance, failure analysis, and statistical process control. Focus on collaborating with cross-functional engineering teams to ensure high-quality standards and adherence to QMS and ISO regulations in a manufacturing environment.

Location: Must be based in Roseville, CA (On-site)

Salary: $85,000 – $114,000

Company

hirify.global is a global healthcare company focused on innovative therapies for vascular and neuro conditions.

What you will do

• Collaborate on development and qualification activities for new and existing products.
• Design and install QC process sampling systems and statistical techniques.
• Perform failure analyses and defect investigations to ensure product quality.
• Interface with engineering departments, customers, and suppliers regarding quality issues.
• Facilitate internal audits and ensure adherence to QMS and global regulations.
• Develop and maintain standard operating procedures and inspection documentation.

Requirements

• Associate’s or Bachelor's degree in Engineering, Life Science, or related field.
• 2+ years of quality engineering or relevant experience.
• Familiarity with QSR, ISO, and applicable medical device regulations.
• Excellent verbal, written, and interpersonal communication skills.
• Proficiency with MS Word, Excel, and PowerPoint.
• Ability to work in office, laboratory, and cleanroom environments.

Nice to have

• Experience in the medical device industry.
• Engineering experience in a manufacturing environment.

Culture & Benefits

• Opportunity to work in a specialized medical device manufacturing environment.
• Collaborative team culture focused on quality and innovation.
• Standard office and laboratory work environment.