Supplier Quality Specialist III (Medtech)

TL;DR

Supplier Quality Specialist III (Medtech): Managing supplier compliance and quality activities in accordance with FDA and ISO regulations with an accent on external audits, supplier qualification, and performance improvement. Focus on driving corrective actions, establishing quality agreements, and ensuring QMS compliance for clinical laboratory operations.

Location: Hybrid in Brisbane, California

Company

hirify.global is a biotechnology company focused on early cancer detection through blood-based diagnostics.

What you will do

• Manage the approved supplier list and coordinate supplier audit schedules.
• Conduct internal and external quality audits to identify risks and drive continuous improvement.
• Establish quality agreements with critical suppliers and maintain comprehensive supplier records.
• Process supplier change notifications and manage non-conformances through to closure and effectiveness review.
• Engage directly with suppliers to enhance the quality of products and services received.
• Support routine Quality processes, including document control, employee training, and quality metrics.

Requirements

• Bachelor's degree in a life science field (genetics or molecular biology preferred).
• 5+ years of experience in manufacturing operations, clinical laboratory operations, or supplier quality.
• ISO 13485 certified Lead Auditor or Certified Quality Auditor (CQA).
• Proficiency in Google Workspace/MS Office and experience with document management systems.
• Ability to travel 10-30% domestically and potentially internationally.
• Must be based in the USA to comply with local employment and hybrid requirements.

Nice to have

• Certified Quality Engineer (CQE) certification from ASQ.
• Experience with quality system methodologies such as CAPA, Lean, 5 Why's, Pareto Analysis, or Six Sigma.
• Knowledge of statistical process control (SPC) techniques and process validations.

Culture & Benefits

• Equal opportunity employer that values diversity and inclusion.
• Professional environment compliant with Federal Employment Laws (FMLA, EEO).
• Collaborative culture requiring interfacing with a wide range of stakeholders.
• Dynamic, fast-paced, and deadline-driven work environment.