The Role
Support site quality and compliance for manufacturing, leading CAPA, audits, complaint handling, supplier evaluation, document and change control (EDMS), risk analysis, and continuous improvement while ensuring regulatory and ISO 13485 alignment.
Summary Generated by Built In
This position is responsible for all quality assurance and control activities for manufacturing site and ensure support for other manufacturing departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation etc.
Key Responsibilities
- In this role- support business in product quality and environmental aspects in dedicated area (SLA/AFAB/CSP/Shipping/ Warehousing)
- local partner for discussion for the business in PS groups / PFMEAs/ NCs/ CAPAs in relation to product quality and safety/ env conditions
- define requirements for process changes, validation purposes as interface with local teams
- interpret and apply applicable regulatory agency regulations and industry standards
- knowledge exchange and unify approach/ procedures across Align sites and partner for discussion with other Align sites
- Identify, analyze and lead the implementation of continuous opportunities of improvement (process and/or quality) focused on exceeding customer needs.
- Supporting internal and cross-functional teams in process quality improvement efforts.
- Ensure that appropriate quality documentation is in place, implemented and effective and improve quality documentation based on needs.
- Coordinate complaint handling and root cause investigation for local departments at the facility.
- Responsible for working with appropriate staff from various department to investigate root causes, put corrective action in place, and monitor results (coordinates CAPA activities locally).
- Carry out or participate in risk analysis regarding process, product or design.
- Be involved in any Corporate or outside agency inspections relating to Quality Management System, if required.
- Carry out and participate the audits (internal, supplier ones) in order to verify the Quality Management System compliance.
- Responsible for ensuring that appropriate quality controls are in place in the process.
- Participate in proactive team efforts to achieve departmental and company goals.
- Serves as general subject matter expert for quality processes & project teams.
- Supports, guides, and coaches the process owners and stake holders.
- Ensures the effective fulfillment of quality objectives and deadlines assigned.
- Ensure site document control procedures comply with local or country specific regulations as well as internal policies and procedures, translations of documents must be controlled.
- Be responsible for maintaining and ensuring the site change control process in Align EDMS, including the review of change control documents and deliverables.
- Review and assist in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations.
- Review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval.
- Co-administration of Aligns EDMS documentation system.
- Create and maintain all hard and soft copy master files for active and archival documentation.
- Perform other duties as assigned.
Skills, Knowledge & Expertise
- Bachelor degree in relevant area (chemistry, engineering, quality) required as minimum
- Post graduate studies related to Quality Management area nice to have
- Minimum of 2+ years of experience in a quality/compliance role (Medical or other regulated areas)
- A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP, etc.).
- Strong written and oral communication abilities required and ability to synthesize information to present as requested.
- Fluent English and Polish required (reading, writing, and conversation).
SKILLS /COMPETENCIES
- Practical knowledge of problem solving tools
- Production processes and validation methods knowledge
- Statistics (Minitab) and SPC knowledge
- ISO 13485 knowledge
- Very good MS Office tools skills (MS Project as well)
- Goal achieving focus
SPECIFIC CERTIFICATIONS/SPECIALTIES/COURSEWORK
- ISO 13485 Internal Auditor certificate nice to have
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 degree in chemistry, engineering, or quality
- Minimum of 2+ years experience in quality/compliance (medical or other regulated areas)
- Broad understanding of Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP)
- Fluent English and Polish (reading, writing, conversation)
- Practical knowledge of problem solving tools
- Production processes and validation methods knowledge
- Statistics knowledge including Minitab and SPC
- Strong MS Office skills, including MS Project
- Experience with document control/change control and EDMS administration
- Ability to conduct and support audits, CAPA, complaint handling, and root cause investigations
- ISO 13485 Internal Auditor certificate
- Post graduate studies related to Quality Management
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?
