Quality Engineer II (Electronics)

TL;DR

Quality Engineer II (Electronics): Developing and implementing quality system elements for medical device products with an accent on testing methodology, failure analysis, and regulatory compliance. Focus on designing QC sampling systems, performing internal audits, and ensuring adherence to QSR and ISO standards within a manufacturing environment.

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

Salary: $95,000 – $127,000

Company

hirify.global is a global healthcare company dedicated to designing and manufacturing innovative therapies for challenging medical 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, suppliers, and customers regarding quality issues.
• Facilitate and perform internal audits to maintain compliance.
• Ensure departmental adherence to the Quality Management System (QMS) and global regulations.

Requirements

• Associate’s or Bachelor's degree in Engineering, Life Science, or related field.
• Minimum 2+ years of quality engineering experience.
• Familiarity with QSR, ISO, and applicable medical device regulations.
• Experience with electronic devices and PCBA manufacturing.
• Must be able to work on-site in Alameda, CA.
• Proficiency with MS Word, Excel, and PowerPoint.

Culture & Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) plan with employer match.
• Paid parental leave and paid sick time.
• Minimum of 15 days of accrued vacation per year, increasing with tenure.
• Collaborative environment focused on revolutionizing treatments for devastating diseases.