Quality Engineer (Wroclaw) (Quality Assurance Specialist)

Quality Wrocław, Poland


Description

Join a team that is changing millions of lives.

Transforming smiles. Transforming lives. Transforming an industry.

 At Align 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. Our teams are constantly pushing the boundaries of what’s possible.

Ready to join us? 

In this role, you will:

  • You will be based in Wroclaw and work closely with Align Technology production site as well as commercial team
  • 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 (Supervisors, Technicians, Clinical, 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 Systems, if required
  • Carry out and participate the audits (internal, supplier ones) in order to verify the QMS 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 Aligns EDMS, including the review of change control documents and deliverable
  • 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 required and minimum of 3+ years of experience in a quality/compliance role

  • A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, MDD 93/42 EEC, GMP, etc.)
  • Have exceptional problem-solving and decision making skills
  • Must have good interpersonal skills and be able to work independently as well as in close collaboration with others
  • Ability to do research and come up with creative, compliant solutions for quality system challenges and attention to detail and ability
  • Native Polish and English language proficiency (written and spoken);
  • Excellent advanced Computer skills in Microsoft Office required

Sound like a good fit? 

 Great! Click the Apply link below to let us know you are interested.  Not the right fit?  Don’t worry, there are lots more opportunities.  Please consider sharing this opportunity with others in your network. 

 About Align

 Invisalign clear aligners, iTero Intraoral scanners, and OrthoCAD digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients

We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Our Applicant Privacy Policies can be found here: http://jobs.jobvite.com/align-tech/