Medical Device Supplier Quality Engineer – Audits & CAPA

Medix™; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Medix in Irvine, CA seeks a Supplier Quality Engineer to ensure externally manufactured components, materials, and assemblies meet quality, engineering, and regulatory requirements.

Responsibilities include supplier qualification, incoming inspection, nonconforming material investigations, supplier corrective actions, and ongoing supplier performance, with travel for audits and qualification activities.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• At least two years of supplier quality or supplier controls experience within medical device manufacturing.
• Candidates without a degree should have at least four years of directly related experience.
• Senior‑level candidates should have at least four years of related experience with a degree or six years without a degree.
• Auditing experience is required, preferably conducting supplier quality audits.
• Experience leading CAPA investigations and supplier corrective actions.
• Strong understanding of supplier qualification, purchasing controls, nonconforming material, root‑cause analysis, and corrective action processes.
• Knowledge of ISO 13485, ISO 14971, and applicable FDA Quality System requirements, including design controls, purchasing controls, risk management, and production and process controls.
• Strong proficiency with Microsoft Word, Excel, PowerPoint, and related business applications.
• Excellent written and verbal communication skills.
• Strong attention to detail and the ability to produce accurate, high‑quality work.
• Ability to manage multiple priorities and follow issues through resolution.
• Ability to work independently while collaborating effectively with suppliers and cross‑functional teams.
• Sound judgment when making decisions and communicating with internal and external stakeholders.
• ASQ Certified Quality Engineer certification preferred.
• Certified Quality Auditor or similar auditing certification preferred.

Responsibilities

• Support the qualification and ongoing monitoring of suppliers that manufacture components, materials, packaging, and assemblies.
• Develop and maintain inspection requirements, acceptance criteria, quality inspection plans, and related supplier documentation.
• Support First Article Inspection activities for new and modified supplier-produced parts.
• Investigate supplier‑related nonconforming materials and determine appropriate disposition.
• Lead or support root‑cause investigations and Supplier Corrective Action Requests.
• Monitor corrective actions to ensure suppliers implement effective and sustainable solutions.
• Develop improvement plans for recurring supplier defects, complaints, and manufacturing‑process issues.
• Support supplier production and process validation activities.
• Conduct supplier quality audits and evaluate supplier compliance with quality agreements, specifications, and regulatory requirements.
• Provide technical guidance to suppliers to improve manufacturing controls and reduce defect rates.
• Monitor supplier quality metrics, identify trends, and communicate performance concerns to internal stakeholders and suppliers.
• Maintain complete and accurate supplier quality records.
• Ensure supplier quality programs comply with applicable medical device regulations and quality standards.
• Partner with Design Engineering and cross‑functional teams to confirm suppliers can consistently meet product and component requirements.
• Create, review, and revise incoming inspection plans.
• Train Quality Control Inspectors on inspection requirements, methods, and acceptance criteria when needed.
• Travel to supplier facilities to perform audits, investigate quality concerns, and support new supplier qualification.

Skills

Auditing experience

CAPA investigations

Root cause analysis

Supplier qualification

Nonconforming material

Quality systems

Cross‑functional collaboration

Communication skills

Decision making

Education

Bachelor’s degree in engineering

ASQ Certified Quality Engineer

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Medix in Irvine, CA seeks a Supplier Quality Engineer to ensure externally manufactured components, materials, and assemblies meet quality, engineering, and regulatory requirements.

Responsibilities include supplier qualification, incoming inspection, nonconforming material investigations, supplier corrective actions, and ongoing supplier performance, with travel for audits and qualification activities.