Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Supporting quality management systems and compliance activities for the development and manufacturing of innovative medical devices with an accent on quality standards, inspection protocols, and statistical analysis. Focus on ensuring product reliability, maintaining regulatory documentation, and collaborating with cross-functional engineering and manufacturing teams.

Location: Must be based in Irvine, California, USA (Onsite 5 days a week)

Salary: $66,400 – $99,600 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Develop and maintain quality standards and protocols for processing materials into finished medical products.
• Collaborate with engineering and manufacturing functions to ensure adherence to quality standards.
• Design and implement inspection and testing methods to evaluate product precision and accuracy.
• Perform statistical analyses to evaluate nonconformance and support resolution efforts.
• Ensure documentation compliance and that corrective measures meet reliability standards.
• Contribute expertise to design quality, production control, and research and development processes.

Requirements

• Baccalaureate degree required.
• 0 years of relevant Quality experience.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Ability to work onsite 5 days a week in Irvine, California.
• Strong analytical skills and foundation in quality engineering principles.
• Ability to manage multiple priorities in a dynamic environment.

Nice to have

• Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering.
• 2+ years of relevant Quality Engineering experience.
• Knowledge of statistical tools (ANOVA, capability analysis, DOE).
• Experience with NCMRs, CAPAs, FMEA, and risk management.
• Familiarity with medical device manufacturing regulations and standards.
• DRM or Design for Six Sigma certification.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan.
• Short-term and long-term disability leave.