Senior Quality Engineer EMEA

Join a team that is changing millions of lives. 

Transforming smiles, changing lives. 

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 diverse and collaborative teams are constantly pushing the boundaries of what’s possible. 

Ready to join us?

About this opportunity 

The primary responsibilities include, but are not limited to, the following areas: QMS documentation management, CAPA process support and execution according to standards by business stakeholders and performing audits.

In this role, you will… 

• Ensure good documentation practices according to QMS.
• Identify, analyze, and lead the implementation of continuous improvement opportunities / projects in quality processes and tools, focused on exceeding customer needs and ensuring compliance with applicable standards and regulations.
• Participate and conduct in yearly internal audit schedules and supplier audit schedules.
• Be involved, as needed, in any global or outside audits.
• Coordinate and support business with CAPA (corrective and preventive actions) process.
• Give QMS and medical device regulations related training to the organization as needed.

In this role, you’ll need … 

• MSc in LifeScience or Quality Engineering degree is desired;
• Certification as Internal Auditor for ISO 13485:2016 is a benefit;
• 5-6 year minimum experience working in Medical Device, Pharma or life science Quality Management position is required.
• Extensive Internal Auditor experience in performing internal quality audits.
• Experience in QMS development and implementation within manufacturing work environment, Medical Device Industry is an additional profit.

Benefits:

• Private healthcare Luxmed,
• Multisport card,
• Private insurance,
• Meal vouchers,
• Co-financing of company products,
• Employee Support Program.