Supplier Quality Engineer

OrthAlign, Inc.

Supplier Quality Engineer at OrthAlign responsible for managing supplier programs in medical device manufacturing. Ensuring quality compliance and collaborating with cross-functional teams in Irvine, California.

Posted 7/29/2026full-timeIrvine • California • 🇺🇸 United StatesJuniorMid-Level💰 $110,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supplier quality management, including conducting audits, managing non-conforming materials, and implementing corrective actions. Proficient in applying ISO standards and leading CAPA investigations to enhance product quality in medical device manufacturing.

Highest-signal resume keywords

Supplier Quality AuditingISO 13485 ComplianceCAPA Investigation LeadershipMedical Device Manufacturing ExperienceASQ Certified Quality Engineer

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier Quality ManagementNon-Conforming Material InvestigationCorrective Action ManagementQuality Metrics MonitoringSupplier Development

Soft Skills

Interpersonal Relationship SkillsNegotiation SkillsAttention to DetailResults-OrientedOrganizational Skills

Tools & Technologies

MS Office Suite

Certifications & Qualifications

ASQ Certified Quality EngineerCertified Auditor

Industry Keywords

Medical Device ManufacturingISO 1497121 CFR Part 820Design ControlsRisk Management

About the role

Key responsibilities & impact

Execute quality-related maintenance and improvement activities related to purchased part qualification of supplier-produced materials, components, and devices to prevent or minimize quality issues.
Contribute to supplier development by driving execution of existing agreements, performing supplier quality audits, and provides technical advice and guidance to suppliers to reduce defect rates.
Monitor supplier-related quality metrics.
Manage supplier related non-conforming material investigations, disposition, and manage supplier corrective actions to resolve product quality issues.
Implements improvement plans for any supplier related complaints or process issues.
Assist in supplier production validations.
Maintain supplier quality records.

Requirements

What you’ll need

BA/BS Engineering-oriented degree
2+ years of experience in the medical device manufacturing supplier controls, or 4+ years of experience in the medical device manufacturing supplier controls
ASQ Certified Quality Engineer, preferred
Certified Auditor, preferred
Auditing experience is required, preferably in the area of supplier audits
Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls
Proficiency leading CAPA investigations and supplier corrective action
Strong interpersonal relationship skills including negotiating and relationship management
Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
Excellent written and verbal communication skills
Ability to work as a collaborative team member as well as independently
Excellent attention to detail, producing high quality output
Results-oriented with appropriate urgency and tenacious follow-up
Flexibility and strong organizational skills with ability to prioritize multiple tasks
Sound judgment when making decisions and communicating with internal and external customers.

Benefits

Comp & perks

Competitive compensation including bonus and equity
Opportunities for career advancement
Full benefits package
An evolving, engaging culture and workplace
Nominated by our employees as a Top Place to Work in Orange County!