Quality Assurance Officer (1 year maternity cover)- Full-timeWe are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.Main Purpose of Role:- Maintenance of the NB 1639 medical device internal quality management system.Managing of daily QA tasks:- Updating and maintenance of documents under the MDD, MDR and IVDR scheme,- Management the IF database,- Collaboration on generic scheme documents,- Publishing of documents on the SGS website,- Bizzmine (Quality Management System); user communication and maintenance.This role will report to the Quality & Regulatory Manager, Business Assurance.It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.Key Accountabilities:- Management of complaints,



compliance queries and appeals,- Management of continual improvement,- Management of document control and records,- Perform quality assurance check on updated quality management system documents,- Release of updated quality management system documents in Bizzmine,- Build a good working relationship with the Integral Medical Device Certification / Competency /- Technical and Clinical Manager(s), and other Global Medical Device Team members,- Undertake personal professional development and ensure appropriate training records are- updated,- Provide technical support to all parts of the business,- Maintain a full knowledge and understanding of SGS procedures, regulations, guidance- documents (e.G., MDCG) and external approval criteria,- Support the development and maintenance of combined scheme documents.Skills & Knowledge- Good working knowledge of quality management systems including CAPA management,- document control and good documentation practices (GDP),- Detail oriented,- Strong organisational skills,- Ability to organise own workload considering priorities set by the global medical device quality- manager,- Ability to adapt quickly and demonstrate flexibility,- Ability to work in a team,- Ability to write clear procedures,- Good working knowledge of the main MS office tools (Word, Excel, Outlook),- Fluent written and spoken English.A nice to have:- Detailed understanding of general medical device regulations MDR and IVDR, and medical- Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001.Experience- Significant work experience in a position with QA responsibility.A nice to have:- Experience working with medical devices,- Auditing experience against recognised standards.Qualifications- Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.G., pharmacy, bioengineering, nurse, or similar)A nice to have:- Medical device training on MDD, MDR, IVDR or ISO 13485Performance Indicators:- Turnaround time for compliance issues/complaints/ appeals,- Efficient running of QMS and release of quality management documents.Why SGS?- Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.- Enjoy a flexible schedule andwork model.- Access SGS University and Campus for continuous learning options.- Thrive in a multinational environment, collaborating with colleagues from multiple continents.- Benefit from our comprehensive benefits platform.Join Us:At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.#J-18808-Ljbffr

📌 Quality Assurance Officer (1 Year Maternity Cover) (Madrid)
🏢 Smartrecruiters
📍 Madrid