The Role
Support maintenance and continuous improvement of the site Quality Management System through document and change control, complaint handling, root cause investigations, CAPA coordination, risk assessments, and inspection support while collaborating with cross-functional stakeholders.
Summary Generated by Built In
The Quality Specialist supports the maintenance and continuous improvement of the site Quality Management System. The role focuses on process and quality improvement, complaint handling, root cause investigations, corrective and preventive actions, risk analysis, document control and change control activities.
The position works closely with supervisors, technicians, engineers, trainers, process owners and other cross-functional stakeholders to ensure that quality requirements, objectives and deadlines are met. The Quality Specialist also supports internal, corporate and external inspections and helps ensure compliance with applicable regulations, internal policies and company procedures.
The position reports directly to the Quality Manager.
Key Responsibilities
- Identify and analyze opportunities for continuous improvement of processes and product quality, with a focus on meeting and exceeding customer expectations.
- Support internal and cross-functional teams in process and quality improvement initiatives.
- Ensure that appropriate quality documentation is established, implemented, maintained and effective.
- Improve quality documentation in response to operational, regulatory and business needs.
- Coordinate complaint handling and root cause investigations for local departments.
- Work with supervisors, technicians, engineers, training teams and other relevant stakeholders to identify root causes and implement appropriate corrective actions.
- Coordinate local Corrective and Preventive Action activities and monitor the effectiveness of implemented actions.
- Conduct or participate in risk assessments related to processes, products and designs.
- Support corporate and external regulatory inspections related to the Quality Management System.
- Ensure that appropriate quality controls are implemented and maintained within operational processes.
- Support, guide and coach process owners and stakeholders on quality-related requirements and activities.
- Monitor the completion of assigned quality objectives, actions and deadlines.
- Ensure that site document control procedures comply with local and country-specific regulations, as well as internal policies and procedures.
- Ensure that document translations are properly reviewed and controlled.
- Maintain and support the site change control process within the Align Electronic Document Management System.
- Review change control documentation, supporting evidence and required deliverables.
- Assist in resolving documentation-related issues, including change control, document archiving, procedures and translations.
- Review electronic documents for formatting, spelling, consistency and clarity before approval.
- Co-administer the Align electronic documentation management system.
- Participate in departmental and company-wide initiatives and support the achievement of organizational goals.
- Perform other duties as assigned.
Skills, Knowledge & Expertise
Education and Experience
- Bachelor’s degree or an equivalent combination of education and professional experience.
- At least six months to one year of experience in a quality, compliance or Quality Management System-related role.
- Previous experience with document control, change control, CAPA, complaint handling or root cause analysis is an advantage.
- Native-level proficiency in the local language.
- Very good written and spoken English, at a minimum B2 level.
- Understanding of Quality Management System principles and quality assurance processes.
- Knowledge of continuous improvement, root cause analysis and corrective and preventive action methodologies.
- Familiarity with risk assessment and risk management principles.
- Knowledge of document control and change control processes.
- Ability to interpret and follow internal procedures, quality standards and regulatory requirements.
- Very good proficiency in Microsoft Office.
- Experience with electronic document management systems is an advantage.
- Strong analytical, research and problem-solving skills.
- Ability to develop creative and compliant solutions to Quality Management System challenges.
- High level of accuracy and attention to detail.
- Good decision-making skills.
- Strong interpersonal and communication skills.
- Ability to work independently and collaborate effectively within cross-functional and interdisciplinary teams.
- Ability to guide, support and coach process owners and other stakeholders.
- Open-minded and resilient approach to working in a fast-paced environment.
- Strong organizational and follow-through skills, with the ability to complete projects within agreed deadlines.
- Ability to manage multiple tasks and priorities in a highly customized working environment.
Job Benefits
- Private healthcare Luxmed,
- Multisport card,
- Private insurance,
- Meal vouchers,
- Co-financing of company products,
- Employee Support Program.
Additionally, the position is eligible for a performance bonus.
The final offer is determined based on the scope of the role, level of responsibility, experience, education, completed training, and key competencies of the candidate.
The final offer is determined based on the scope of the role, level of responsibility, experience, education, completed training, and key competencies of the candidate.
Align Technology, in addition to statutory benefits, provides a comprehensive set of perks designed to support employee comfort and professional development. Available benefits include, among others: private medical care through Luxmed, a Multisport card, private life insurance, a social fund, meal subsidies, and discounts on company products. The range of additional benefits may vary depending on the position level, nature of work, and work location.
Information regarding compensation policies and salary ranges for this position can be found in the Compensation Policy available under the Corporate Disclaimers section of our careers site: https://jobs.aligntech.com/corporate-disclaimers
We encourage all candidates to review this document before moving forward in the recruitment process.
Information regarding compensation policies and salary ranges for this position can be found in the Compensation Policy available under the Corporate Disclaimers section of our careers site: https://jobs.aligntech.com/corporate-disclaimers
We encourage all candidates to review this document before moving forward in the recruitment process.
Zachęcamy do zapoznania się z naszą Procedurą Sygnalistów. Szczegółowe informacje znajdziesz, klikając w poniższy link:
Align Technology (Poland).pdf
About
Your growth and well-being:At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:Health and well-being programs to keep you thriving in both body and mind.Employee-exclusive discounts on Invisalign products.Learning opportunities through online learning resources and support for your individual development plans.Inclusive, global workplace that fosters collaboration, recognition and belonging.Country and/or role specific details will be shared with you by your recruiter during the interview process. Discover Align: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.Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.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.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. 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 our global differences 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.
Skills Required
- Bachelor's degree or equivalent combination of education and experience
- At least six months to one year of experience in quality, compliance, or QMS-related role
- Previous experience with document control, change control, CAPA, complaint handling, or root cause analysis
- Native-level proficiency in the local language
- Very good written and spoken English (minimum B2 level)
- Understanding of Quality Management System principles and quality assurance processes
- Knowledge of continuous improvement, root cause analysis and corrective and preventive action methodologies
- Familiarity with risk assessment and risk management principles
- Knowledge of document control and change control processes
- Very good proficiency in Microsoft Office
- Experience with electronic document management systems (e.g., Align EDMS)
Align Technology Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Align Technology and has not been reviewed or approved by Align Technology.
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Healthcare Strength — Health coverage includes medical, dental, vision, life, and both short‑ and long‑term disability, along with AD&D and wellness resources. Select locations add region‑specific programs such as medical coverage and Multisport, reinforcing breadth.
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Strong & Reliable Incentives — A corporate bonus plan outlines performance‑based rewards and eligibility, and compensation is described as competitive in commercial roles. Incentive structures in sales are portrayed as offering strong on‑target earnings potential.
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Retirement Support — Retirement programs feature a 401(k) plan with company contribution mechanisms, profit sharing, and a defined contribution pension plan. These elements emphasize long‑term financial security alongside salary and bonus.
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The Company
What We Do
Twenty years ago, we pioneered the world's first clear aligners. Since then, we have continuously innovated with new products and technologies that are revolutionizing treatments for doctors and their patients. Invisalign clear aligners and the iTero Intraoral scanner help dental professionals achieve the clinical results they expect and deliver effective, advanced dental options to their patients. Helping change millions of lives, one smile at a time. Discover your straight path to a bright future at Align. As a part of our smart, diverse and fast-moving global team, you'll make an impact for the market leader that's moving an industry forward. Want to find out what’s next for us—and for you?
