Design 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 Design 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 the Company. This is a key technical position, affecting part quality for both installed base and new products

In this role, you will…

The Design 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 the Company. This is a key technical position, affecting part quality for both installed base and NPI products.

AS a Design Quality Engineer (DQE) you will plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of medical equipment including cooperated with the design and development team, and apply quality management principles throughout the product life cycle.
DQE's main responsibilities include:
• Review design documents and specifications, to ensure that they meet relevant standards and regulations
• Participant in risk assessment, identify and reduce potential risk quality
• Take part in the design and verification process

In this role, you’ll need …

Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
Good ability to comprehend multi-disciplinary systems and processes
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
Computer skills (Microsoft Word, Excel, PowerPoint)
Working knowledge in Statistical Tools, e.g. miniTab (Measurement Systems Analysis, Process Capability and Statistical Process Control)
Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc. preferred
Strong written and verbal communication skills
Strong organizational skills

EDUCATION and/or EXPERIENCE

Bachelor's Degree in engineering or equivalent

At least 4 years of experience in Design quality

Experience from medical device industry - Big advantage

Excellent written and spoken English

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.

#LI-MA1

#LI-Hybrid