Supplier Quality Engineer

OrthAlign Inc.•Irvine, CA

About The Position

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Supplier Quality Engineer responsible for managing supplier programs for manufacturing, packaging, and other operational processes, as well as ensuring that quality programs are in compliance with regulatory requirements. This role supports the OrthAlign mission by reporting and acting on trends in supplied material and component quality requirements. This position works closely with the design engineering and cross-functional teams to ensure that suppliers are capable of meeting the OrthAlign product quality requirements.

Requirements

BA/BS Engineering-oriented degree and 2+ years of experience in the medical device manufacturing supplier controls, or 4+ years of experience in the medical device manufacturing supplier controls
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

Nice To Haves

ASQ Certified Quality Engineer, preferred
Certified Auditor, preferred

Responsibilities

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.