Staff Quality Compliance Engineer (Medtech)

TL;DR

Staff Quality Compliance Engineer (Medtech): Devise and lead execution of actions to improve compliance, effectiveness, and efficiencies of Quality Compliance and PMS processes with an accent on monitoring key quality metrics and scaling workflows. Focus on leading CAPA investigations, identifying process risks, and ensuring alignment with FDA QSR, ISO 13485, and EU MDR regulations.

Location: Hybrid in San Jose, CA. For US-Based Candidates Only. Work Authorization: Citizen / Permanent Resident required.

Salary: $144,000–$169,000 per year

Company

hirify.global revolutionizes treatment for benign prostatic hyperplasia through innovation in surgical robotics.

What you will do

• Lead special projects for Quality Compliance and Post-Market Surveillance, including planning, execution, and continuous improvement.
• Identify process risks in QMS and implement sustainable solutions considering cross-functional interdependencies.
• Represent Quality Compliance on cross-functional initiatives, influencing stakeholders to meet objectives.
• Perform and lead CAPA, including root cause investigations and corrective actions.
• Define performance requirements, establish monitoring, and evaluate process effectiveness.
• Review regulations and standards to ensure compliance of products, processes, and services.

Requirements

• Bachelor’s degree in engineering, science, or technical discipline.
• 8+ years in medical device industry, including 5+ years in quality systems, engineering, or compliance.
• Working knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR.
• Knowledge of computer software validation, GxP systems, 21 CFR Part 11.
• Ability to lead projects, strong analytical and problem-solving skills.
• Excellent communication, collaboration in matrixed environment; up to 10% travel.

Nice to have

• Master’s degree in engineering, science, or technical discipline.
• Prior supervisory or managerial experience.

Culture & Benefits

• Comprehensive health coverage, wellness programs, on-site gym.
• 401(k) with employer match, short/long-term disability, life insurance.
• Flexible/PTO, paid parental leave, paid holidays.
• Work/life blend culture with induction program, management training.
• Focus on innovation, patient-first, continuous career growth.