Production and Suppliers Quality Engineer Leader

Department: Quality

Location: EMEA-Israel

Description

About this opportunity

We are seeking a highly motivated and detail-oriented Production and Supplier Quality Team Leader . This role is responsible for ensuring the

highest quality standards in production and supplier-provided components, driving continuous improvement, and maintaining compliance with

medical industry regulations.

Key Responsibilities

In this role, you will…

• Lead and manage the Production & Supplier Quality team.
• Develop and implement quality control processes for materials and products.
• Collaborate with suppliers on quality agreements, audits, and corrective actions.
• Oversee incoming inspections and ensure compliance with ISO 13485, FDA, MDR.
• Drive continuous improvement using Six Sigma, Lean, RCA.
• Conduct internal/external audits and manage CAPA, NCR, and risk documentation.
• Mentor team members and foster a culture of quality excellence.
  
  

Skills, Knowledge & Expertise

In this role, you’ll need …

• Bachelors in engineering or quality management.
• 10+ years in QA within medical device/high-tech manufacturing corporates.
• Strong regulatory knowledge (ISO 13485, FDA).
• Certifications: CQE, Six Sigma, Lead Auditor.
• Leadership, analytical, and problem-solving skills.
  
  

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Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.