Quality Assurance Engineer EMEA

2 tygodni temu

Wrocław, Województwo dolnośląskie, Polska Align Technology, Inc. Pełny etat

Join a team that is changing millions of lives.

Transforming smiles,changing lives.

AtAlign 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. Ourdiverseand collaborativeteams are constantly pushing the boundaries of what's possible.

Ready to join us?

About this opportunity

This position is responsible for all quality assurance and control activities for EMEA operations and manufacturing EMEA and ensure support for other manufacturing departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation etc.

In this role, you will...

  • 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.

In this role, you'll need ...

  • Bachelor degree in relevant area (chemistry, engineering, quality) required as minimum
  • 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 required (reading, writing, and conversation).
  • Fluent Polish is preferable (reading, writing, and conversation).
  • 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)

Sound like a good fit?

Great Click the "Apply" link to let us know you are interested. Not the right fit? Don't worry,Alignis 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 istransforming 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 andOrthoCADdigital 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 thethingsemployees say make Align Technology a great place to work.

We respect your privacy. Please reviewourApplicant Privacy Policiesfor additional information.

Global Diversity Statement:

At Align, we believe in the power of a smile, and we know that everysmile isas unique asour employees. As we grow, we will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a cultureof open-mindedness and compassion forallouremployees. 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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