EMEA Senior Manager QARA

Sol-Millennium Europe Sp. z o.o.O firmie

  • Warszawa, mazowieckie

  • Ogłoszenie wygasło 21 dni temu
  • Kierownik / Koordynator

Europe's leading distributor of sterile single use medical equipment for hospitals, clinics and health centers, as
well as the pharmaceutical industry, is currently looking for a Sourcing Manager. The company is uniquely focused on improving the Healthcare Professionals safety at work, by providing the latest safety medical device innovations, as well as investing in research and development. 

EMEA Senior Manager QARA

Workplace: Warszawa

The Senior Manager QARA – EMEA provides leadership, direction and hands-on involvement with the Company's quality managements system in support of internal and external compliance standards, company objectives, and customer requirements. The Senior Manager QARA – EMEA’s primary responsibilities include monitoring and ensuring compliance to international requirements, staying abreast of new and revised regulations, assure New Product Introductions comply with internal and international regulatory requirements, assure on-market products comply with internal and international regulatory requirements, manage internal and external audits and inspections. Assure implementation and compliance to UK and EU Authorized Representative responsibilities.

  • Serves as a liaison between Company/business partners and the national Competent Authorities (Ministries of Health)
  • Assist with certain device registrations, as required
  • Make a current copy of Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
  • Ensure compliance to applicable US FDA, Health Canada, EU Medical Device Regulations/Medical Device Directive, CFDA and other international country-specific requirements and policies
  • Ensure currency and implementation of new and changing country and agency-specific regulations
  • Manage inter-related global quality system compliance on all medical devices from concept through post-market activities; manage
  • Integrate knowledge of the Quality Policy and Business Objectives into work practices to augment the business
  • Participate in the preparation of internal and external audit program
  • Develop responses to core quality system external and internal audits
  • Perform quality reviews, audits, investigations, and CAPAs
  • Perform supplier assessments, qualifications, and audits
  • Maintaining and improving QMS processes, plans, and reviews
  • Prepare charts and track quality metrics in support of quality planning for Management Review
  • Coordinate training of all employees on procedures, policies or other quality related training programs
  • Collaborate with global and regional QA/RA teams.

Desired qualifications:

  • University degree in science, engineering, business, management or similar
  • Fluent English
  • Extensive knowledge or certifications in EU Medical Device Directive and Regulation 
  • ASQ certification (e.g. Certified Quality Manager, Certified Quality Auditor, Certified Quality, Engineer)
  • RAPS certification 
  • Experience in Quality Assurance and Regulatory Affairs for medical devices
  • Experience as external auditor in the scope of medical devices

We offer:

  • Excellent working environment with office located in the city center
  • Career development opportunities in an international environment
  • Competitive salary / Attractive salary and benefits followed by permanent job contract
  • Be a part of a very dynamically growing sourcing organization

If you are interested, please send your CV in English via Aplikuj button below.

Prosimy o zawarcie w CV klauzuli: „Wyrażam zgodę na przetwarzanie danych osobowych zawartych w mojej ofercie pracy dla potrzeb niezbędnych do realizacji procesu rekrutacji prowadzonego przez Sol-Millennium Europe sp. z o.o. z siedzibą w Warszawie zgodnie z ustawą z dnia 29 sierpnia 1997 r. o ochronie danych osobowych (t.j. Dz. U. z 2016 r., poz. 922)”.
Jednocześnie wyrażam zgodę na przetwarzanie przez ogłoszeniodawcę moich danych osobowych na potrzeby przyszłych rekrutacji.
Informujemy, że Administratorem danych jest Sol-Millennium Europe sp. z o.o. z siedzibą w Warszawie przy ul. Twardej18. Dane zbierane są dla potrzeb rekrutacji. Ma Pani/Pan prawo dostępu do treści swoich danych oraz ich poprawiania. Podanie danych w zakresie określonym przepisami ustawy z dnia 26 czerwca 1974 r. Kodeks pracy oraz aktów wykonawczych jest obowiązkowe. Podanie dodatkowych danych osobowych jest dobrowolne.

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