Director Supplier and Production Quality

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

Production and Suppliers Quality Director

This position will focus on improving product quality through data analysis, investigation, issue resolution and collaboration with both internal and external parties. This person will be responsible for driving the non-conforming material process and root cause investigation through coordination with engineering & R&D organizations.

You will be responsible for making final decisions on production and supplier quality along with ensuring NPI, engineering, supply chain and fulfilment as well as production effective achievement of quality and compliance objectives.

In the role of Production & Suppliers Quality director you will oversee iTero production in various global Align facilities; you’ll also be managing suppliers and contract manufactures for iTero from around the globe.

In this role, you will…

• Drive product quality improvements in production and with suppliers
• Manage a team of quality engineers & the QC Dept.
• Manage the NCM and MRB processes.
• Lead analysis of defects data (NCM, RMA and DOA)
• CAPA/ SCAR creation / resolution and maintain records as specified by the Align quality system
• Lead QC team and drive incoming inspection improvements, such as direct- to- stock, reduction of MRB and non-conforming material inventory.
• Interface with other functions on supplier related defects
• Conduct root cause analysis on product quality issues, identify trends, and communicate with Engineering/ R&D on a regular basis.
• Be responsible to oversee that Operations are working according to released and validated work instructions to ensure that a device conforms to its specifications.
• Be responsible for process- related Validations across the company – process, support SW, mold, jigs
• Ensure the creation of accurate, complete and timely records and DHRs
• Set the yearly suppliers audits plan and execute with the team
• Be responsible for evaluating current suppliers, approving new suppliers and disqualifying suppliers
• Support the introduction of iTero production lines in other Align facilities around the globe and with external contract manufacturers.
• Work with Align Global on the integration and harmonization of Purchasing controls and Production and process controls related SOPs, supplier’s audits and supporting IT systems.
• Support PFMEA creation and update and any other process and suppliers' risk- related activities
  
  

Additional Responsibilities

• Be aware of and comply with the Align Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/ position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Support external bodies audits on- site
• Perform internal audits.
  
  

In this role, you’ll need …

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.

• Strong communication skills, verbal and written.
• Proficient in English – written & verbal.
• Computer skills - PLM, ERP, CRM, Microsoft office etc.
• Team player, collaborating with many different internal and external functions.
  
  

EDUCATION And EXPERIENCE

B.Sc. in Engineering (Electronics, Mechanics, Materials, Chemistry, Biomed) or equivalent

At least 15 years of experience in quality positions in medical device industry

Experience in leading supplier and production quality in active medical device.

Proven experience participating in notified body/FDA audits.

Experience in working with suppliers and subcontractors and contract manufacturers in multiple countries

At least 10 years of experience in a managerial role

Deep understanding of medical device regulatory requirements including specifically in regards toa Purchasing controls and Production and Process Controls

Proven qualification in root cause investigation methods

MDR implementation experience is an advantage.

Lead Auditor Certification from an accredited organization - Advantage

Working knowledge in statistical tools (MSA, Cpk); Six Sigma green belt is an advantage.

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.