Johnson & Johnson Careers
Business Quality Specialist
Requisition ID: 1905722139W
The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, diabetes care, infection prevention, cardiovascular disease, sports medicine, and aesthetics. This segment is comprised of our Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.
Location: Zagreb, Croatia
Full time unlimited contract
Responsible for Medical Device Vigilance in Croatia and supporting other SEE countries as required, lead the local QA organization and support regional organization to ensure implementation, maintenance and upgrading of the local Quality System and SOPs in order to drive compliance of all GXP related processes and support SEE region (CEE region as required).
- Lead the local QA organization and support regional organization to ensure implementation, maintenance
- and upgrading of the local Quality System and SOPs in order to drive compliance of all GXP related processes.
- Responsible person for Medical Device vigilance ensuring local organization compliance
- Ensure efficient information flow and effective communication of all relevant quality and regulatory (when required) matters within the Croatian affiliate (supporting SEE region as required).
- Having overview of local and international regulatory and legislative requirements and communicate them to local/regional and to Global Quality Assurance when required.
- Ensure an adequate process is in place to report and monitor the predefined KPI's, in alignment with Global QA and local affiliate. Assure that gaps are addressed appropriately and escalate critical trends to Management Team and Global QA.
- Provide quality oversight and direction to local third parties and ensure that they are qualified to perform their activities.
- Ensure readiness of local affiliate for all GxP regulatory inspections. Ensure management of external inspections, complaints, deviations, recalls, counterfeits and product tampering.
- Ensure that local and/or regional (SEE, CEE) audits and self-inspections are performed within the organization and at 3rd parties, as appropriate. Ensure that any deficiencies identified through audits or other means are addressed.
- Ensure that within the local affiliate a GxP training program is established and training timely performed, documented and its effectiveness checked.
Suitable applicant will have:
- Previous experience in Quality is essential.
- Experiences as responsible person for Medical Devices Vigilance and training in the field of vigilance of medical devices are preferred.
- It is preferred that experience includes 3+ years in Quality Role within a Medical Device or other GMP controlled environment.
- Knowledge regarding quality standard ISO 9001:2015 requirements are preferred
- Experience in Quality Issue Management (Nonconformance and CAPA management)
- Change management experience and influencing and interpersonal skills
- Strong collaboration skills and ability to build partnerships internally and externally
- Excellent written and oral English communication skills are required
- Advanced knowledge of Excel, PowerPoint, Word
- Bachelors or Masters degree in university school of medicine, dentistry, pharmacy, technology, electrical engineering, mechanical engineering, chemistry, business
- An opportunity to be part of a global market leader
- A dynamic and inspiring working environment
- Many opportunities to work on challenging projects and assignments
- Possibilities for further personal as well as professional development
- Motivating financial remuneration
- Many employee benefits such as life and pension insurance, 5 weeks of holidays etc.
Johnson & Johnson d.o.o. Croatia (7396)