Oferta opublikowana14.05.2024
Oferta wygasa08.08.2024
Tryb pracystacjonarna
Rodzaj umowyumowa o pracę
Tryb rekrutacjirekrutacja stacjonarna
Wymiar etatupełny etat
Branżait
Your 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.
- 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.
- Work with Production, Customer Success, Marketing, Engineering, Clinical, Training, and all other functions to increase Quality Awareness.
Our requirements
- 6+ years of experience in Quality area, peferably in Medical Device or Pharma industry
- Bachelor’s or Master Degree in Science (LifeScience) or Technical discipline is required;
- Fluency in Polish, business proficiency in English
- 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.
- Must be proficient with computers and standard software programs such as Microsoft programs and Minilab
- Must be able to work independently as well as in close collaboration with others.
Benefity
Kawa i herbata
Ubezpieczenie na życie
Parking dla pracowników
Owoce
Dodatkowe świadczenia socjalne
Zniżki na firmowe produkty i usługi
Prywatna opieka medyczna
Program poleceń pracowników
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