Lead Supplier Quality Auditor (Medical Devices)

Location: South Korea, Taiwan, or Dubai, with 50–60% travel across APAC

Company

hirify.global develops and supports medical device solutions focused on improving lives through innovation and quality.

What you will do

• Conduct technical supplier audits across APAC against applicable standards, regulations, and hirify.global specifications.
• Review production, materials control, and manufacturing processes to identify quality improvement opportunities.
• Manage and follow up on supplier corrective action plans resulting from audits and assessments.
• Escalate supplier quality and regulatory issues that may affect product quality or compliance.
• Collaborate with Supplier Quality Auditors, Engineers, subject matter experts, and cross-functional teams to resolve supplier issues.
• Maintain audit records, contribute to supplier quality KPI reporting, and support risk-based annual audit scheduling.

Requirements

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, or a related field.
• Required quality auditor accreditation from ASQ CQA or CBA, IRCA Lead Auditor, RABQSA Lead Auditor, or an equivalent government certification body.
• 8+ years of experience in medical device manufacturing or a related industry, with 5+ years in quality auditing preferred.
• Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, and ISO 13485.
• Experience with master validation plans, IQ/OQ/PQ protocols and reports, pFMEAs, and risk management documentation.
• Proficient written and spoken English required; a second language is a plus.

Nice to have

• ASQ Supplier Quality Engineer Certificate.
• Additional language proficiency.

Culture & Benefits

• Work on impactful projects in the medical device industry.
• Build relationships with suppliers around the globe.
• Develop professional skills and grow a career in a supportive, collaborative environment.
• Travel across APAC is expected for 50–60% of the role.