Department: Quality

Location: EMEA-Poland

Description

The primary responsibilities include, but are not limited to, the following areas: implementing, maintaining, and ensuring a compliant quality management system in EMEA region, meeting the requirements of ISO 13485, FDA’s Quality System Regulations (QSR) and Regulations (EU) 2017/745, including management of compliance, global QA projects implementation and execution, change management, , vendor QA assessment and EMEA QMS KPI’s. The scope of the job position contains the facilities in EMEA, and the AFAB EMEA.

Sr Quality Assurance Engneer EMEA ensures that projects and directions given by global QA are properly implemented and executed across EMEA.

Key Responsibilities

• Ensure that the QMS on EMEA level is compliant with the requirements of ISO 13485, FDA’s Quality System Regulations (QSR) and Regulations (EU) 2017/745.
• Identify and manage projects to improve the effectiveness of the QMS on EMEA level.
• Support EMEA functions outside QA-RA to document their processes effectively and efficiently in the applicable QMS documentation templates.
• 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 in yearly internal audit schedules and supplier audit schedules.
• Oversee and execute the EMEA supplier onboarding assessment process, including periodic reassessments.
• Be involved, as needed, in any global or outside agency inspections.
• Contributes to CAPA process.
• Implement and maintain standardized local QMS KPI’s, aligned with global KPI’s, and implement and maintain systems to archive these and make these easily retrievable. Report out on these KPI’s.
• Provide the EMEA QMS KPI’s to global QA to prepare the global level management review meetings.
• Escalate nonconformities in the QMS to upper management, where appropriate.
• Work with Production, Customer Success, Marketing, Engineering, Clinical, Training, and all other functions to increase Quality Awareness.
• Give QMS and medical device regulations related training to the organization as needed.
• Participate in proactive team efforts to achieve departmental and company goals.
• Perform other duties as assigned.
  
  

Skills, Knowledge & Expertise

• Minimum of Bachelor’s Degree in Science (LifeScience) or Technical discipline is required;
• MSc in LifeScience or Quality Engineering degree is desired;
• Certification as Internal Auditor is required for ISO 13485:2016;
• 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 the Medical Device Industry.
• A broad understanding of applicable Quality System regulations, such as GMP, FDA’s QSR, ISO 13485 and Regulations (EU) 2017/745.
• Strong written and oral communication abilities required and ability to synthesize information to present as requested.
• Fluent English required (reading, writing, and conversation).
• Certified as an Internal Auditor.
• ASQ Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt are a plus.
  
  

Job Benefits

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

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.

Equal Opportunity Statement

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.