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Client:

Align Technology

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

601706182731

Job Views:

13

Posted:

23.01.2025

Expiry Date:

09.03.2025

Job Description:

About this opportunity

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.

In this role, you will:

1. 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.
2. Identify and manage projects to improve the effectiveness of the QMS on EMEA level.
3. Support EMEA functions outside QA-RA to document their processes effectively and efficiently in the applicable QMS documentation templates.
4. Ensure good documentation practices according to QMS.
5. 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.
6. Participate in yearly internal audit schedules and supplier audit schedules.
7. Oversee and execute the EMEA supplier onboarding assessment process, including periodic reassessments.
8. Be involved, as needed, in any global or outside agency inspections.
9. Contribute to the CAPA process.
10. 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.
11. Report out on these KPI’s.
12. Provide the EMEA QMS KPI’s to global QA to prepare the global level management review meetings.
13. Escalate nonconformities in the QMS to upper management, where appropriate.
14. Work with Production, Customer Success, Marketing, Engineering, Clinical, Training, and all other functions to increase Quality Awareness.
15. Give QMS and medical device regulations related training to the organization as needed.
16. Participate in proactive team efforts to achieve departmental and company goals.
17. Perform other duties as assigned.

In this role, you’ll need:

1. Minimum of Bachelor’s Degree in Science (Life Science) or Technical discipline is required; MSc in Life Science or Quality Engineering degree is desired.
2. Certification as Internal Auditor for ISO 13485:2016.
3. 5-6 years minimum experience working in Medical Device, Pharma or life science Quality Management position is required.
4. Extensive Internal Auditor experience in performing internal quality audits.
5. Experience in QMS development and implementation within the Medical Device Industry.
6. A broad understanding of applicable Quality System regulations, such as GMP, FDA’s QSR, ISO 13485 and Regulations (EU) 2017/745.
7. Must be proficient with computers and standard software programs such as Microsoft programs and Minitab.
8. Must be able to work independently as well as in close collaboration with others.
9. Ability to do research and come up with creative, compliant solutions for quality system challenges.

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