Manager, QMS 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. Ourdiverseand collaborativeteams are constantly pushing the boundaries of what's possible.

Ready to join us?

About this opportunity

This position is mainly responsible for accomplishing results through management of professional individual contributors and/or skilled, support individual contributors in the following areas: support for operational departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation, document control activities, QMS training, etc.

This position reports directly to Director, QA Operations EMEA.

In this role, you will...

• Ensure that the EMEA QMS is in compliance with the requirements of ISO 13485, FDA's Quality System Regulations (QSR) and Regulations (EU) 2017/745.
• Maintain the EMEA Quality Management System (QMS) and keep it simple, pragmatic and easy to understand.
• Identify, analyze and lead the implementation of continuous opportunities for improvement (process and/or quality) focused on exceeding customer needs.
• Lead 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 business 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).
• Take leadership in risk analysis regarding process, product or design.
• Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
• Provides direction and management guidance to employees according to established policies and procedures.
• Be involved in any global or outside agency inspections relating to Quality Management System, if required.
• Manage the audits (internal, global and supplier) in order to verify the Quality Management System compliance.
• Prepare, in collaboration with the EMEA QA-RA team and other relevant stakeholders, the EMEA level management review of the EMEA QMS meetings.
• 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 stakeholders.
• 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.
• Escalate nonconformities in the QMS to upper management and provide solutions, where appropriate.
• Ensure review and assistance in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations.
• Ensure review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval.
• Ensure proper co-administration of Aligns EDMS documentation system.
• Give QMS and medical device regulations related training to the organization as needed.
• Work with Production, Customer Success, Marketing, Engineering, Clinical, Training, and all other functions to increase Quality Awareness.
• Comply with all safety policies, practices and procedures.
• Report all unsafe activities to superior and/or Human Resources.
• Perform other duties as assigned.

In this role, you'll need...

• Bachelor's or Master's Degree, Post graduate studies related to Quality Management area or related experiences would be a plus.
• 3+ years of experience in supervising/leading role or equivalent combination of education and extensive proven experience in QMS development and implementation within the Medical Device Industry.
• Extensive practical Internal Auditor experience in performing internal quality audits
• A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP, etc.).
• Quality assurance experienced in the whole value stream (Supplier-Process-Customer)
• Native speaker of local language and English language proficiency (written and spoken).
• Excellent advanced Computer skills in Microsoft Office required.
• Ability to provide direct supervision to individuals.
• Demonstrated leadership; ability to listen and speak effectively, ability to solve problems and communicate issues; ability to work on multiple projects.
• Must have exceptional level of commitment and a positive can-do attitude.
• 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 exceptional problem-solving and decision-making skills.

Sound like a good fit?

Great Click the "Apply" link to let us know you are interested. Not the right fit? Don't worry, Align is 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 is transforming 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 and OrthoCAD digital 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 the things employees say make Align Technology a great place to work.

We respect your privacy. Please review our Applicant Privacy Policies for additional information.

Global Diversity Statement:

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 will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. 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.