Sr. Manager, Quality Assurance Engineer (Medical Devices)

Location: Union City, California, United States

Salary: $172,000–$198,000 annually, depending on experience, plus an annual potential bonus and comprehensive benefits.

Company

hirify.global develops specialty surgical tables and disposable and reusable patient-care products for spine and orthopedic procedures.

What you will do

• Lead, mentor, train, and provide technical support to the Quality Assurance Engineering group.
• Manage quality resources, staffing, performance, development, schedules, priorities, and departmental budget.
• Plan and manage internal quality audits and support external regulatory audits and inspections.
• Drive corrective and preventive actions, audit response plans, supplier quality activities, and ongoing audit readiness.
• Support new product introductions, design projects, sterilization validation, sterile product release, and quality system improvements.
• Coordinate quality documentation and collaborate with cross-functional teams on regulatory and compliance initiatives.

Requirements

• Bachelor’s degree in engineering, science, business, or a related field; a master’s degree is preferred, or equivalent experience.
• At least ten years of quality experience, including five years in management, plus experience in medical device manufacturing.
• Three to five years of experience with sterile medical devices is required.
• Knowledge of ISO and QSR requirements, including FDA 21 CFR Part 820, Part 806, Part 11, ISO 13485:2016, EU MDR 2017/745, and ISO 14971.
• Experience with FDA-regulated recalls or field corrections, audits, regulations analysis, procedure writing, and quality system development.
• Strong technical leadership, communication, decision-making, planning, prioritization, analytical, and Microsoft Office 365 skills.

Culture & Benefits

• Comprehensive benefits package.
• Annual potential bonus.
• Focus on quality, regulatory compliance, patient outcomes, and cross-functional collaboration.