Quality Engineer II (Manufacturing Operations)

TL;DR

Quality Engineer II (Manufacturing Operations): Supporting quality programs within a Quality Management System for the development and manufacturing of medical devices with an accent on quality standards, inspection/testing methods, and statistical analysis of nonconformance. Focus on implementing corrective measures, ensuring compliant documentation, and applying reliability, design quality, and risk-management expertise to production processes.

Location: Irvine, California, United States of America

Salary: $79,200.00 - $118,800.00 (USD)

Company

hirify.global is a global healthcare technology company building solutions to alleviate pain, restore health, and extend life.

What you will do

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into finished products.
• Collaborate with engineering and manufacturing to ensure quality standards are in place.
• Design and specify inspection/testing methods and equipment; conduct quality assurance testing and statistical analyses to evaluate nonconformance.
• Support resolution of product/material nonconformance and ensure corrective measures meet reliability standards.
• Ensure documentation is compliant with applicable requirements.
• Apply expertise across design quality, incoming materials, production control, product evaluation, reliability, inventory control, and R&D as it relates to product/process quality.

Requirements

• Requires a Baccalaureate degree with at least 2 years of relevant Quality experience, or a Master’s degree with 0 years of relevant experience.
• Unrestricted U.S. work authorization required at time of hire and for duration of employment (U.S. sponsorship is offered exclusively for Principal-level roles and above).
• Ability to collaborate effectively with cross-functional teams.
• Experience applying quality engineering principles to manufacturing/production quality activities.

Nice to have

• Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related field.
• Knowledge of statistical tools such as ANOVA, capability analysis, and DOE.
• Experience with NCMRs and CAPAs.
• DRM or Design for Six Sigma certification.
• Experience with process validation, test method validation, and medical device manufacturing regulations/standards.
• Experience with FMEA and risk management.

Culture & Benefits

• Onsite work 5 days a week in Irvine, California.
• Eligible for a short-term incentive called the hirify.global Incentive Plan (MIP).
• Health, dental, and vision insurance plus Health Savings Account and Healthcare Flexible Spending Account (for regular employees working 20+ hours/week).
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and employee assistance program (for regular employees).
• Tuition assistance/reimbursement and global well-being program (Simple Steps).