Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Warsaw, Masovian, PolandJob Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/
J&J MedTech is recruiting for a Commercial Quality Senior Specialist reporting to the Quality Supervisor DC Poland and to be based in Warsaw (Poland).
Overall purpose of the job
The role will partner with Quality team and other departments in the organization to ensure the processes under Quality Management System are compliant and aligned to J&J standards and local requirements.
Supervision and participation in the processes of the Quality Management System for the Johnson & Johnson Distribution Center in accordance with regulations, standards and global policies of the quality company.
Initiating and supervising activities leading to thorough checking, identification of quality problems and solving them by introducing corrective and preventive actions.
Essential duties and responsibilities
- Quality support in processes related with storage /distribution of medical devices for Poland and Baltic Countries
- Quality support in medical devices repack-relabel activities, release repacked/relabel products
- Quality support in Environmental Controls, Validation, Calibration & Maintenance
- Document Management, documents updating, distribution, archiving, periodic reviews, controlled copies
- Quality support in training management, quality agreements for the activities that are under the Quality Management System
- Participation in the implementation of corporate quality standards and procedures including compliance analysis
- Corrective and preventive actions (CAPA), non-conformities, quality investigations, change control and projects, risk analysis, supplier qualification, quality metrics in accordance with the requirements of the Quality Management System
- Participation in preparing for audits and participating in their course
- Participation in quality projects, new IT tool implementation and supporting continuous improvement
- Collaboration with local and corporate Johnson & Johnson's departments.
Essential knowledge and skills
- Master’s degree and Quality compliance proficiencies
- Experience with work at a similar position preferably with medical devices or pharma background
- Knowledge of legal/regulatory requirements regarding quality/compliance
- Quality Management knowledge, quality tools and IT quality systems usage
- Advanced in English and fluent in Polish (local language)
- Communication skills, creativity, reliability
- Willingness to learn, collaborative, engaged, proactively bring solutions
- Microsoft Office – Excel, Word, Power Point skills
Core competencies required for this role
- Organizational skills, systematicity, reliability
- Analytical and interpersonal skills
- Ability to work in a team and manage time/self-discipline in carrying out tasks
Job location
