Senior Manager, QMS EMEA

Department: Quality

Location: EMEA-Poland

Description

The Senior Manager, QMS EMEA ensures that projects and directions given by global QA are properly implemented and executed across EMEA.

This position reports to the Director, QA Operations, EMEA.

The location of your office will be Wrocław. We can support the relocation process to Wrocław if needed.

Role expectations

• Comprehensive management of a team of approximately 10 specialists. Contribute proactively to team efforts to meet departmental and organizational goals.
• Ensure that the EMEA-level Quality Management System (QMS) complies with ISO 13485, FDA Quality System Regulations (QSR), and EU Regulation 2017/745.
• Lead and manage projects aimed at enhancing the efficiency and effectiveness of the EMEA QMS.
• Support EMEA teams outside of QA-RA in documenting their processes accurately and efficiently using the appropriate QMS documentation templates.
• Promote and enforce good documentation practices across the QMS.
• Ensure the compliance and proper deployment of Documentation Services and the Learning Management System.
• Identify, evaluate, and lead the implementation of quality process and tool improvements, focusing on customer satisfaction and adherence to applicable standards and regulations.
• Develop and execute annual internal and supplier audit schedules, including multisite audits, ensuring adherence to the plan.
• Oversee the EMEA supplier onboarding assessment process and manage periodic reassessments.
• Participate in global or external agency inspections as required.
• Lead and ensure the CAPA process operates effectively and efficiently across the EMEA region.
• Establish and maintain standardized local QMS KPIs, aligned with global metrics, and implement systems to store and retrieve these KPIs easily. Report on these metrics regularly.
• Collaborate with stakeholders to prepare EMEA-level KPI reviews and multisite management review data, taking the lead in meetings when necessary.
• Provide EMEA QMS KPIs to the global QA team for inclusion in global management review meetings.
• Escalate significant QMS nonconformities to senior management as appropriate.
• Work with teams such as Production, Customer Success, Marketing, Engineering, Clinical, and Training to foster a strong Quality Awareness culture.
• Deliver training on QMS and medical device regulations as needed.
  
  

What We're Looking For

• Minimum of Bachelor's Degree in Science (LifeScience) or Technical discipline is required;
• Fluent English and Polish required (reading, writing, and conversation).
• +4 years of experience in team management and more than 10 years of expertise as a specialist in Quality Management Systems (QMS). .
• Experience working in Medical Device would be a strong plus.
• Extensive Internal Auditor experience in performing internal quality audits.
• Certification as Internal Auditor for ISO 13485:2016.
• Experience in QMS development and implementation.
• A broad understanding of applicable Quality System regulations, such as GMP, FDA's QSR, ISO 13485 and Regulations (EU) 2017/745.
• 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.
  
  

Benefits

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

Zachęcamy do zapoznania się z naszą Procedurą Sygnalistów. Szczegółowe informacje znajdziesz, klikając w poniższy link:

Align Technology (Poland).pdf

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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 are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. 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.

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Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.