Sr. Production and Suppliers Quality Engineer

Join a team that is changing millions of lives.

Transforming smiles, changing lives

 

At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what’s possible.

 

Ready to join us? 

About This Opportunity

The Sr. 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.

In this role, you will…

• 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.
  
  

In this role, you’ll need …

• Bachelor's Degree in engineering or equivalent applicable experience
• 7+ years of experience in quality in highly regulated industry
• Fundamental knowledge of ISO13485:2016 and FDA requirements for medical device industry - advantage
• 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
• Working knowledge in Statistical Tools (Measurement Systems Analysis, Process Capability and Statistical Process Control)- preferred
• Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc.- preferred
• Strong written and verbal communication skills in English
• Strong organizational skills
  
  

Sound like a good fit?   

 

Great! Click the "Apply" link to let us know you are interested. Not the right fit? Don’t worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.    

About Align  

  

Align Technology is a publicly traded medical device company that is transforming smiles and changing lives. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world’s largest manufacturer of custom 3D-printed materials.   

  

By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work – these are just some of the things employees say make Align Technology a great place to work.   

  

We respect your privacy. Please review our Applicant Privacy Policies for additional information.  

 

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 will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. 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

It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.