Design Quality Assurance Manager (Medical Devices)

Location: Hybrid role based in Hercules, California, United States; employees must live within commuting distance of the office.

Salary: $137,600–$189,200 base salary annually, plus eligibility for a variable annual bonus.

Company

hirify.global develops, manufactures, and markets research and clinical diagnostic products for science and healthcare.

What you will do

• Allocate design quality assurance resources across concurrent new product development and life cycle management projects, forecast capacity, and report design assurance metrics.
• Own design control deliverables and approvals across planning, inputs, outputs, reviews, verification, validation, design transfer, changes, and Design History File readiness.
• Assess applicable regulations and standards, maintain applicability matrices and gap plans, and ensure requirements traceability and product classification.
• Govern portfolio risk management, including hazard analysis, FMEAs, risk controls, benefit-risk evaluation, and post-production feedback.
• Oversee software lifecycle assurance, cybersecurity, product safety, EMC, usability, labeling, and global market-access evidence.
• Lead escalations, audits, inspections, CAPA activities, design assurance procedures, and the development of design quality engineers while partnering with R&D, Regulatory Affairs, Operations, and senior leadership.

Requirements

• Bachelor’s degree or equivalent in a scientific or engineering discipline.
• 8+ years of relevant quality systems experience with supervisory experience, or an equivalent combination of education and experience.
• Experience in medical device, pharmaceutical, or another regulated industry, including knowledge of manufacturing processes and risk management regulations and standards.
• Knowledge of FDA 21 CFR 820/QMSR, MDSAP, EU IVDR, ISO 13485, ISO 14971, global EMC and safety standards including IEC 61010 and IEC 61326, and cybersecurity including IEC 81001.
• Direct experience supporting FDA inspections, MDSAP audits, and/or notified body assessments as a design control subject-matter expert.
• Communication, public speaking, decision-making under pressure, word processing, spreadsheet, self-prioritization, and management of multiple urgent projects are required.
• Ability to collaborate actively to resolve difficult technical issues while remaining customer-oriented and goal-focused.

Nice to have

• Experience in a global organization or interfacing with multiple manufacturing locations.
• Quality Engineer, Quality Manager, Six Sigma Green Belt, or Six Sigma Black Belt qualification.

Culture & Benefits

• Hybrid work environment with collaborative teams spanning the globe.
• Medical plans, HSA funds, fertility stipend, life and disability coverage, paid parental leave, and 401k with profit sharing.
• Employee stock purchase program, mental health support, pet insurance, wellness programs, paid time off, and Employee Resource Groups.
• Learning and development opportunities, education benefits, and student debt relief program.
• Annual bonus eligibility depends on individual objectives and company performance.