What are the responsibilities and job description for the Sr. Quality Systems Engineer - CAPA position at Align Technology?
Description
As a Sr. Quality Systems Engineer- CAPA, you will be responsible for maintaining and executing the Invisalign Multi-Site Corrective and Preventive Action (CAPA) process to ensure compliance with regulatory requirements and improve product quality and processes. You will also assist with training, documentation and change control processes.
Role expectations
- Lead and manage the CAPA process, including investigation, root cause analysis, and implementation of corrective and preventive actions.
- Collaborate with cross-functional teams to identify and resolve quality issues.
- Develop and maintain CAPA documentation, ensuring accuracy and compliance with regulatory standards.
- Partner with global teams to provide an independent, technical review of CAPAs
- Monitor the effectiveness of CAPA actions and make necessary adjustments to ensure continuous improvement.
- Conduct regular CAPA reviews and audits to ensure compliance and effectiveness.
- Provide training and support to team members on CAPA processes and best practices.
- Prepare and present CAPA reports to management and regulatory bodies as required.
- Stay updated on industry regulations and standards related to CAPA and quality management.
- Report on status of CAPA system in alignment with site and corporate KPI’s
- Support harmonization of QMS elements following Global initiatives and incorporation of systems.
- Lead and support ongoing Quality Improvement projects and initiatives.
What we're looking for
Applicant Privacy Policies :
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 are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. 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 :
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
Your growth and well-being :
At Align, every smile matters. We are committed to supporting your health, contentment, and professional development through tools and initiatives designed to help you thrive. While benefits may vary by location, you can expect the following wherever you join us :
Country-specific details will be shared with you by your recruiter during the interview process.
Discover Align :
At Align Technology, we are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.
We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.
As part of our commitment to innovation, Align Technology includes Exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.
Eager to learn how we embrace diversity and nurture employee well-being?
Explore Align's culture here!
Want to discover more about exocad and Cubicure ? Click on their names for additional information.
