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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 Quality Assurance Specialist / Manager is responsible for implementing and maintaining local regulatory compliance after pre-market approval. Responsible for ensuring locally that organizational goals and objectives regarding regulatory compliance is achieved.
Establishes documentation requirements for local processes and assures ongoing maintenance of document control system. Responsible for reporting on the performance of local quality and regulatory activities and metrics. Responsible for ensuring that local organization is aligned with regional QA strategies and execution.
In this role, you will…
- Ensure Korea local QMS is established and managed well according to defined global policy and relevant regulatory requirements.
- Acts as the local Quality System Representative and performs those duties specified in the Quality Manual and associated procedures to ensure compliance of operations against requirements such as development of local quality procedure, management of quality documents and handle of various quality issues for ensuring product quality and safety.
- Ensures that post-market obligations, including AE/FSCA, complaint reporting, nonconformity management and CAPA are adequately documented and addressed in a timely manner to ensure specified timelines are met.
- Provides relevant quality training to Align Korea employees including 3PL (if necessary) on post-market surveillance such as QMS process or quality compliance to prevent potential risks, increase quality mindset and improve local QMS.
- Develops and implements Align QMS harmonize with global quality policy, related local regulations and standards. review, analyze and report on quality discrepancies related to Korea local QMS. Ensures that local requirements that impact the quality system are appropriately addressed by relevant QMS procedures and that ongoing operations are compliant and reflected in procedures.
- Manage for any internal & external audit to continue Korea business and implement defined QMS with at least annual RAQA review with stakeholders. Conducts internal audits in accordance with documented requirements and timelines.
- Ensures continuous supply with internal & external regulatory compliance through on-time regulatory actions such as KGMP renewal, MFDS re-evaluation and MD license renewal.
- Review ad & promotional materials and provide a regulatory guidance according to global policy and local regulatory requirements as a regulatory reviewer.
- Keep pertinent stakeholders within the company apprised of any changes to the regulatory landscape affecting the performance of existing and new Company products or quality system requirements. Provides expertise to support business efforts locally based on RAQA requirements, and any other applicable worldwide regulatory requirement and business needs.
- Ensures that required Align, Suppliers and Distributors licenses/permits/ certificates and Quality Systems needed to conduct business have been obtained and are maintained accordingly
In this role, you’ll need …
- Experience in performing quality processes mapping, quality workflows and writing quality procedures.
- Experience as a RAQA in an importing company related to medical devices.
- Knowledge of regulatory requirements for medical devices, including product registration and good distribution practices from country scope.
- Ability to work cross-functionally with multiple projects, solving problems and communicating issues. Strong interpersonal, verbal, and written communication skills is required.
- Ability to execute project/program tasks with general supervision and little guidance.
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.
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