Align is the industry leader and innovator in medical devices which focuses on revolutionizing the dental and orthodontic industry. Align, the makers of Invisalign ® is looking for a. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry. The
In this role, you will…
- Responsible for the establishment and improvement of QMS processes
- Lead and write SOPs, WIs, Forms and Templates for Global processes, including automated solutions when applicable
- Working with QMS leaders from different regions and business units to maintain effective QMS and conduct training as appropriate
- Promote the use of techniques for continuous improvement such as Lean Manufacturing, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)
- Participate in cross-functional teams in the development of new processes or changes related to current processes in meeting external standards and customer requirements
- Undertake special projects as required
- Contribute to continuous improvement activities
- Support the business during internal and external audits
- Collaborate with cross-functional teams, to establish and document procedures and work instructions
Typically:
- Bachelor’s degree in Science, Engineering, or with any relevant background
- Minimum of 5 years of relevant experience in QA at Medical Device company
- Knowledge of quality management principles specific to the medical device industry, including ISO 13485, FDA QSR, and EU MDR (an advantage)
- Experience in Supplier Quality Management is highly desirable
- Strong problem-solving skills
- Strong written and verbal communication skills
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Ability to lead end to end activities
- English – High level proficiency required (written and spoken)
- High level computerized system skills
- Certified Quality Engineer (CQE / CQM) – an advantage
