Quality Engineer, Sustaining (Medtech)

TL;DR

Quality Engineer, Sustaining (Medtech): Support manufacturing operations and quality system compliance for surgical robotics devices with an accent on FDA QSR, ISO 13485, and EU MDR requirements. Focus on nonconformance investigations, process validations, risk management, and continuous improvement to ensure device reliability and regulatory adherence.

Location: On-site in San Jose, CA. Work Authorization: Citizen / Permanent Resident required

Salary: $101,390 - $119,280 a year

Company

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

What you will do

• Support manufacturing operations by ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Perform line clearance, in-process inspections, final release activities, and nonconformance investigations including root cause analysis.
• Assist with cleanroom controls, environmental monitoring, and process validations (IQ, OQ, PQ).
• Participate in risk management activities like pFMEA updates and control plan reviews.
• Identify quality issues, support cross-functional teams in production challenges, and maintain quality documentation.
• Assist with internal/external audits and new product introduction activities.

Requirements

• 2-4 years of experience with a Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related), Life Sciences, or equivalent.
• 1–3 years in quality, manufacturing, or engineering in a regulated environment (medical device preferred).
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 requirements.
• Basic understanding of root cause analysis tools (5-Why, fishbone) and nonconformance investigations.
• Ability to read engineering drawings and use basic metrology tools (calipers, micrometers).

Nice to have

• Experience in medical device manufacturing (Class II or III devices).
• Knowledge of process validation (IQ, OQ, PQ) and statistical tools (SPC, Gage R&R, AQL).
• Experience with MES or eDHR systems.
• Exposure to cleanroom operations and environmental monitoring.

Culture & Benefits

• Comprehensive benefits including full medical coverage, wellness programs, on-site gym, 401(k) with employer match, short/long-term disability, life insurance, flexible/paid time off, paid parental leave, and paid holidays.
• 10% annual bonus and RSUs at offer.
• Focus on work/life blend, continuous career growth, cross-functional team building, and pathological optimism in innovation.
• Live induction program, management development, and commitment to employee health and wellbeing.