Supplier Quality Engineer

OrthAlign, Inc.; Irvine (CA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Competitive compensation including bonus and equity

Opportunities for career advancement

Full benefits package

Engaging workplace culture

Job summary

OrthAlign, Inc., based in Irvine, California, is seeking a Supplier Quality Engineer to manage supplier programs and ensure compliance with quality regulations. The successful candidate will execute quality-related activities and work closely with design engineering teams.

This role requires a BA/BS degree in engineering and 2+ years of experience in medical device manufacturing. Benefits include competitive compensation and a full benefits package.

Qualifications

• 2+ years of experience in medical device manufacturing supplier controls.
• ASQ Certified Quality Engineer preferred.
• Auditing experience, preferably in supplier audits.

Responsibilities

• Execute quality-related maintenance and improvement activities.
• Contribute to supplier development by driving execution of agreements.
• Manage supplier-related non-conforming material investigations.

Skills

Supplier quality audits

ISO 13485

ISO 14971

21 CFR Part 820

CAPA investigations

MS Office Suite

Interpersonal relationship management

Education

BA/BS Engineering-oriented degree

Job description

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.

NOTE: You must have the ability to report daily to our headquarters in Irvine, California.

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 providing 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. Implement improvement plans for any supplier‑related complaints or process issues. Assist in supplier production validations. Maintain supplier quality records.

Qualifications

• Your BA/BS Engineering‑oriented degree and 2+ years of experience in medical device manufacturing supplier controls, or 4+ years of experience in 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 & 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

• 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!

It is an exciting time at OrthAlign – make your next career move with us!

NOTE: We are unable to provide any type of sponsorship at this time.