Senior Quality Engineer (Operations)

Location: On-site in San Diego, California; must be within commuting distance. Up to 20% travel is expected, primarily for contract manufacturer visits and supplier audits.

Salary: $130,000–$150,000 annually, depending on experience, skills, and qualifications. Discretionary bonuses and/or equity grants may also be available.

Company

hirify.global develops non-surgical brain–computer interfaces and safety-critical medical technology to restore and expand human interaction and autonomy.

What you will do

• Lead manufacturing quality activities, including quality plans, inspection methods, acceptance criteria, process controls, and production readiness.
• Monitor quality metrics, investigate nonconforming products and production issues, and lead root-cause investigations and CAPA implementation.
• Lead or support IQ/OQ/PQ process validation, manufacturing process characterization, sampling plans, and validated-state maintenance.
• Manage supplier and contract manufacturer quality through qualification, audits, performance monitoring, quality agreements, and corrective actions.
• Support design transfer, process FMEAs, control plans, engineering change control, design reviews, and commercialization readiness.
• Maintain manufacturing quality documentation and support audits, FDA inspections, Notified Body audits, and QMS improvement.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical or science field.
• At least 7 years of quality engineering experience in an FDA-regulated medical device environment, including manufacturing support, process validation, and control plan development.
• Experience with manufacturing quality systems, supplier quality, corrective actions, and quality documentation.
• Working knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, and applicable medical device standards.
• Ability to work hands-on on the manufacturing floor and collaborate with Manufacturing Engineering, Supply Chain, Operations, R&D, and Regulatory teams.
• Visa sponsorship is not available for this position.

Nice to have

• ISO 13485:2016 Lead Auditor certification, CQE, or CQA certification.
• Experience with engineering drawings, GD&T, electrical schematics, electromechanical assembly, and inspection.
• Lean Manufacturing, SPC, capability studies, MSA, Gage R&R, 5S, Kaizen, and poka-yoke experience.
• 8+ years of medical device quality engineering experience, including 3+ years in manufacturing.
• Class III implantable device experience and experience with FDA or Notified Body inspections or regulatory submissions.

Culture & Benefits

• Full-time, exempt W-2 employment in the United States.
• Subsidized medical and dental insurance for employees and dependents.
• Life, short-term disability, and long-term disability insurance.
• 401(k), discretionary unlimited paid time off, and flexible spending account.
• Cross-functional work focused on healthcare technology, collaboration, and innovation.