Sr Quality Engineer (Medtech)

TL;DR

Sr Quality Engineer (Medtech): Ensuring design quality and regulatory compliance throughout the new product development lifecycle for medical devices with an accent on design control, risk management, and regulatory standards. Focus on authoring quality documentation, driving root cause analysis for compliance issues, and overseeing design verification and validation activities.

Location: Onsite in Irvine, CA, United States

Salary: $105,000 - $135,000

Company

hirify.global is a medical technology company specializing in innovative non-invasive monitoring and healthcare solutions.

What you will do

• Lead quality engineering activities across new product development programs to ensure strict regulatory compliance.
• Author, review, and approve critical documentation, including design control records, risk management files, and test protocols.
• Act as the primary quality representative on cross-functional teams from the concept phase through commercial release.
• Utilize structured problem-solving methodologies to identify root causes and resolve compliance issues.
• Plan and oversee design verification and validation activities to ensure products meet user needs.
• Manage nonconformances, CAPAs, and engineering changes within the Quality Management System (QMS).

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 6-8+ years of quality engineering experience within a regulated medical device environment.
• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• Proven experience managing DHF records, risk files, and design control documentation.
• Expertise in QMS processes, including CAPA, change control, and document control.
• Must be able to work onsite in Irvine, CA, United States.

Nice to have

• Experience with Class II and/or Class III medical device development.
• Familiarity with FDA submission pathways such as 510(k), PMA, or De Novo.
• ASQ Certified Quality Engineer (CQE) professional certification.
• Knowledge of IEC 60601, IEC 62366, or ISO 80601 series standards.

Culture & Benefits

• Comprehensive health package including medical, dental, vision, and life insurance.
• Financial incentives including a 401(k) plan and up to 10% annual performance bonus.
• On-site facilities such as a wellness clinic, fitness center, and café.
• Generous leave policy including vacation, sick leave, and paid maternity leave.
• Additional perks such as Flexible Spending Accounts and Pet Insurance.