Sr Eng, Supplier Quality (Medical Devices)

Location: Tijuana, Baja California, Mexico

Company

hirify.global develops medical products and therapies used in hospitals, clinics, and homes worldwide, with a mission focused on saving and sustaining lives.

What you will do

• Plan, coordinate, schedule, and execute domestic and international supplier audits.
• Monitor supplier performance and follow up on audit findings against FDA CFR 820, ISO 13485, and ISO 9000 requirements.
• Develop inspection and testing techniques for supplier materials and analyze component characteristics to determine inspection status.
• Lead supplier approval by assessing manufacturing capabilities, quality systems, and risks.
• Work with suppliers, sourcing, manufacturing, and quality engineering teams to resolve problems and reduce MRB inventory.
• Manage timely implementation of supplier Corrective Action Reports and support reductions in incoming inspection cycle time.

Requirements

• Engineering degree.
• Knowledge of FDA CFR 820, ISO 13485, and ISO 9000 requirements.
• English communication skills required.
• Three or more years of experience is desirable.
• Previous quality auditing experience, particularly supplier audits.
• Strong documentation, communication, and problem-solving skills.

Nice to have

• ISO 13485 Lead Auditor certification.

Culture & Benefits

• Work connected to hirify.global’s mission of saving and sustaining lives.
• Collaborative culture emphasizing courage, trust, ownership, and accountability.
• Equal employment opportunity and reasonable accommodation support.