Sr. Quality Engineer (Medtech)

TL;DR

Sr. Quality Engineer (Medical Devices): Providing on-site quality engineering support for high-volume manufacturing of regulated cardiac medical devices with an accent on regulatory compliance, root cause analysis, and process optimization. Focus on leading CAPA investigations, performing statistical process control (SPC), and ensuring adherence to FDA and ISO 13485 standards.

Location: On site in Cypress, CA (Orange County)

Salary: $99,000 - $129,000

Company

hirify.global is a leading digital healthcare company that creates wearable biosensors and cloud-based data analytics to detect, predict, and prevent cardiac disease.

What you will do

• Provide daily on-site quality engineering support to ensure product quality and regulatory compliance in high-volume manufacturing.
• Lead investigations for nonconformances and deviations using structured root cause analysis (5 Why, Fishbone, Fault Tree).
• Own CAPA investigations and implementations to drive systemic improvements and timely closure.
• Utilize Statistical Process Control (SPC) and process capability analysis (Cp/Cpk) to evaluate and improve process performance.
• Support process validation activities (IQ/OQ/PQ) and review validation protocols and reports.
• Partner with Operations and Engineering to reduce defects, scrap, and rework through mistake-proofing (poka-yoke) solutions.

Requirements

• Bachelor's degree in Mechanical, Biomedical, Electrical, or Industrial Engineering.
• 5+ years of Quality Engineering experience in a regulated industry.
• Deep understanding of FDA-regulated manufacturing (21 CFR 820, ISO 13485, FDA QMSR).
• Proven experience with CAPA, Nonconformance management, Risk Management (ISO 14971), and Process Validation.
• Experience with ERP systems (e.g., SAP, QAD) and electronic Quality Management Systems (eQMS).
• Must be based in or able to work on-site in Orange County, CA.

Nice to have

• Master's degree in an engineering discipline.
• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.
• ISO 13485 Lead Auditor certification.
• Experience with wearable medical devices and statistical software such as Minitab.

Culture & Benefits

• Opportunity to work on life-changing cardiac health solutions impacting patients worldwide.
• Rapidly growing environment with ample opportunities for career advancement and skill growth.
• Inclusive workforce culture that celebrates diverse backgrounds and perspectives.
• Collaborative, fast-paced environment driven by a commitment to putting patients first.