Job Description

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Join a team that is changing millions of lives.

Transforming smiles, changing lives.

At , we believe a great smile can transform a person\xe2\x80\x99s life, so we create technology that gives people the confidence to take on whatever\xe2\x80\x99s 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\xe2\x80\x99s possible.

Ready to join us?

About this opportunity

The APAC Regulatory and Quality Assurance Department has a position in the Southeast Asia (SEA) for a Quality Assurance (QA) Manager to support local & regional functions of the Department. This role will lead, establish, maintain, coordinate and support the SEA Regulatory Compliance in meeting Align\xe2\x80\x99s Quality goals via an effective Quality Management System to ensure that business processes across SEA are in full compliance with medical device regulations within the region and Align\xe2\x80\x99s internal requirements.

The position also monitors changes to applicable laws and legislations that could affect the organization in Southeast Asia and provides guidance to the site leadership team on matters relating to quality. This position is based in Align\xe2\x80\x99s Singapore office and reports directly to the Director, Regulatory Affairs and Quality Assurance, APAC, in the APAC corporate HQs located in Singapore.

In this role, you will\xe2\x80\xa6

Quality Assurance

• Develop and maintain SEA sites Quality Management System procedures to comply with local requirements and Align Global Quality Framework, Global QMS Policies and Global Standard Operating Procedures which ties to the \xe2\x80\x98One Align\xe2\x80\x99 and \xe2\x80\x98Quality First\xe2\x80\x99 principles to establish a Global Harmonized Quality standard.
• Develop and maintain sites CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification.
• Implements the quality audit program per APAC approved audit schedule, ensuring site audit readiness and conducts successful internal/ external audits. Drive closure to audit findings including investigation, implementation, and effectiveness checks.
• Leads the preparation and coordination with site personnel to ensure the success of site audits by External Regulatory bodies as well as Corporate/APAC internal audits. Drive closure to audit findings including investigation, implementation, and effectiveness checks.
• Assume the MR role for Singapore GDPMDS and SEA sites, as applicable.
• Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with site process owners to define improvements.
• Supports new business expansion in SEA, ensuring its quality compliance.
• Assists with all department projects as required.

In this role, you\xe2\x80\x99ll need \xe2\x80\xa6

• Must be proficient in English, with a working knowledge of other languages in Southeast Asia.
• Thorough understanding of Southeast Asia medical device laws and regulations.
• In depth knowledge of Quality System regulations \xe2\x80\x93 GMP, GDP, ISO 13485, etc., with its relevant SEA implementation experience and audit skills.
• Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
• Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
• A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
• Must be able to work independently, and handle both small and large matters with equal effectiveness and enthusiasm.
• Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change.
• Bachelor Degree in Science or Engineering preferred.
• 5-8 years of experience in Quality Assurance role at medical device company is required.
• Ability to research and propose well-thought out solutions when dealing with challenges.

Sound like a good fit?

Great! Click the "Apply" link to let us know you are interested. Not the right fit? Don\xe2\x80\x99t 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\xe2\x80\x99s 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 \xe2\x80\x93 these are just some of the things employees say make Align Technology a great place to work.

We respect your privacy. Please review our 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.

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Align Technology