Jr. Quality Assurance Engineer EMEA

Posted Yesterday
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Hiring Remotely in Poland
Remote
Junior
Healthtech • Biotech
The Role
Support local quality processes: document control, CAPA coordination, complaint handling, audits, supplier evaluation, risk analysis, change control in Align EDMS, and continuous improvement efforts.
Summary Generated by Built In
This position is mainly responsible for document control activities, coordination of initial quality analysis and ensure support for operational departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation, metrology activities etc.

Key Responsibilities
In this role, you will… 
  • Identify, analyze and support with 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.
  • Support with coordinating complaint handling and root cause investigation for local departments at the facility.
  • Responsible for working with appropriate assigned areas (Supervisors, Technicians, Engineers, training, etc.) 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 (as co-auditor) and participate the audits (internal, supplier ones) in order to verify the Quality Management System compliance.
  • Support with ensuring that appropriate quality controls are in place in the process.
  • Participate in proactive team efforts to achieve departmental and company goals.
  • 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.

Skills, Knowledge & Expertise

In this role, you’ll need … 
  • Bachelor degree or equivalent in experience is required as a minimum.
  • Minimum of 0,5-1 years of experience in a quality/compliance role.
  • Native speaker of local language and very good English language (B2 level as minimum: written and spoken).
  • Ability to do research and come up with creative, compliant solutions for Quality Management System challenges and attention to detail.
  •  Must have good interpersonal skills and be able to work independently as well as in close collaboration with others.
  • Have very good problem-solving and decision making skills.
  • Very good computer skills in Microsoft Office required.

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 yearly 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.
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. 
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 or equivalent
  • 0.5-1 years experience in a quality/compliance role
  • Native speaker of local language and very good English (minimum B2 level)
  • Experience with quality processes: CAPA coordination, complaint handling, supplier evaluation, metrology, risk analysis
  • Experience with document control and change control in Align EDMS (co-administration)
  • Very good computer skills in Microsoft Office
  • Ability to research and develop compliant QMS solutions and strong attention to detail
  • Good interpersonal skills; able to work independently and collaboratively
  • Strong problem-solving and decision-making skills
  • Ability to participate in audits (internal and supplier) as co-auditor

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.

  • 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.
  • 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.
  • 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.

Align Technology Insights

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The Company
HQ: San Jose, CA
10,001 Employees
Year Founded: 1997

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?

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