Production and Supplier Quality Engineer

Department: Operations

Location: EMEA-Israel

Description

About this opportunity

The Production and Supplier Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for Align. This is a key technical position, affecting part quality for both installed base and NPI parts.

Key Responsibilities

In this role, you will…

• Collaborate with cross-functional teams in planning, reviewing and approving process validation documents for production processes, jigs, etc.
• Improve supplier quality performance for assigned suppliers.
• Lead supplier audits as required by Align supplier audit schedule and supplier performance management requirements
• Perform supplier qualification processes - including quality requirements definition & communication, control plan negotiation, COT definition, etc…
• Participate in supplier selection process and specification reviews with suppliers to ensure that purchased components/materials meet Align specifications
• Assure supplier compliance to Align QMS and regulatory requirements through supplier monitoring process.
• Ongoing supplier’s evaluation & monitoring – source inspections, statistical analysis.
• Specify quality characteristics and inspection plans for components, subassemblies, and finished devices
• Develop positive relationships and work closely with Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers.
• Lead and collaborate with cross-functional teams to manage supplier change notifications through risk based evaluation
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
• Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically Failed on Arrival/Install (DOA/RMA) issues, Field Failures, and Factory defects.
• Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.
  
  

Skills, Knowledge & Expertise

In this role, you’ll need …

• Bachelor's Degree in an engineering or equivalent applicable experience
• 5 years of experience in quality engineering in the medical device industry or highly regulated industry
• Fundamental knowledge of ISO13485:2016 requirements for medical device industry
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
• Ability to work independently with minimal supervision
• Strong working knowledge in process validations
• Working knowledge in Statistical Tools (Sample size, Measurement Systems Analysis, Process Capability and Statistical Process Control)
• Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc.-
• Strong written and verbal communication skills in English
• Strong organizational skills
  
  

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Global Diversity Statement

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

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.