DXCTS QUALITY SPECIALIST
Sant Cugat del Valles, ES
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a DX CTS Quality Specialist ike you.
Mission
Contribute to the definition, maintenance, monitoring, and improvement of the Quality System of Commercial Technical Service of the DxBU (DxCTS), in accordance with applicable regulations (ISO 13485, 820CFR, MDSAP, IVDR, etc.), actively participating in the development and management of SOPs, documentation, KPIs, Management Review, audits, and the follow-up of non-conformities and CAPAs, in order to meet the Quality planning.
What your responsibilities will be
- Participate in the development of the quality culture of DxCTS
- Take part in identifying and developing business processes, ensuring that the quality and effectiveness of supported products and offered services are considered, as well as compliance with regulatory requirements and global quality policies and procedures.
- Promoting quality culture throughout the organization
- Monitor subcontracted technical service activities
- Evaluate distributors and Support & Service Providers (S&SSP) through audits and/or quality questionnaires.
- Monitor performance and maintain the qualification status of suppliers.
- Participate in defining the quality standards that subcontracted companies must follow.
- Deploy and maintain the DxCTS quality management system
- Manage quality system documentation efficiently, ensuring it is easily understandable and useful for users.
- Ensure compliance with the procedures and guidelines that make up the quality system, as well as the availability of associated records.
- Conduct internal and external audits.
- Prepare periodic reports on the performance of the quality system, including key indicators (KPIs), identifying opportunities for improvement and the corresponding corrective and preventive actions.
- Participate in audits and inspections to provide support in quality matters
- Contribute to risk identification, assessment and mitigation
- Participate in maintaining DxCTS ISO 27001 certification
- Oversee IT activities and controls required by ISO 27001.
- Keep DxCTS documentation updated as required by ISO 27001.
- Implement CAPAs related to ISO 27001 within DxCTS and ensure the implementation of those related to IT.
- Participate in the execution of tests associated with the Business Continuity Plan (BCP).
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
- Bachelor’s degree in Health Science, Engineering or a related field
- 2-5 years of experience in a similar position
- Organized, meticulous, analytical and strategic planner
- Adaptability, able to handle multiple requests, priorities, and changes
- Ability to manage meetings with people from various countries
- Fluent English (speaking and writing)
What we offer
It’s a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function DX CTS Quality Specialist help you grow professionally.
Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
Grifols is an equal opportunity employer.
Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package
Contract of Employment: Permanent position
Flexibility for U Program: 2 days remote working
Location: Sant Cugat del Vallès.
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Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]