Medical Device Specialist

Company DescriptionSGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance, and sustainability.Main purpose of the roleTo support planning and conduct management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standardsTo assist in business development as required and to provide specific technical support to expand the Company’s capability to offer valued services to customersKey AccountabilitiesConduct audits (either desk-based or on client’s sites) in accordance with established procedures and approved plans, maintaining a high standard of service deliveryEnsure completion of all assigned work and relevant documentation and upload into the SGS system in accordance with required procedures, deadlines and standards to fulfil customer expectationsProvide accurate and timely reporting as required by line management to assist the planning and management of operationsEnsure effective follow-up and timely close-out of non-conformities in accordance with established proceduresManage personal schedule to work efficiently and to meet target changeability requirements as defined by the Operations ManagerProject-manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standardsUndertake personal professional development and ensure appropriate training records and personal logs are updated and submitted to the NB to maintain relevant auditor registrations and competency codes and relevant industry knowledgeProvide technical support and staff training to all parts of the business to enhance the service capability of the businessSupport business development activities as required (including follow up and/or referral of inquiries, sales visits, assistance at events, seminars, etc.) to enable on-going growth of the businessMaintain a full knowledge and understanding of SGS procedures and external approval criteria to allow efficient and effective technical reviewsQualificationsSkills & KnowledgeEducation: University or technical college degree in relevant sciencesSpecialisations:Biology or microbiologyChemistry or biochemistryComputer and software technologyElectrical, electronic, mechanical engineering or bioengineeringHuman physiologyMedicinePharmacyPhysics or biophysics4 years of professional experience in relevant fieldRelevant industry such as: medical device industry and subcontractors, in vitro diagnostic industry and subcontractors, sterilization department or sterilization service providerAppropriate knowledge of conformity assessment procedures laid down in medical device regulation 2017/745, FDA, SFDAKnowledge of medical devices quality management system ISO 13485:2016 and must hold IRCA approved ISO 13485:2016 lead auditor certificationDemonstrate 2 years working knowledge on MDT/MDN codes per Regulation (EU) 2017/2185 codes and 4 years of industrial working experience knowledge specifically for MDS 1005, MDS1006 & MDS1010Knowledge of standards such as cleanroom ISO 14644 series, biological evaluation ISO 10993 series, sterilization standards (ISO 11135, ISO 11137), clinical investigation ISO 14155, risk management of medical devices ISO 14971, and common specifications and guidance associated with the product covered by the MDA, MDN or MDS code per regulation (EU) 2017/2185). Knowledge on MDCG documents for medical devicesKnowledge of clinical evaluations of product categories covered by regulation (EU) 2017/2185 codesKnowledge of relevant products standards covered by the regulation (EU) 2017/2185 codesMust be able to demonstrate excellent working knowledge of medical device management and regulatory systems, standards, and compliance/auditing techniquesEffective interpersonal skills; able to develop good working relationships with people at all levelsMust be IT literate i.e., competent in the use of MS Office applications and preferable experience of using large and complex databasesWillingness to learn and adapt to change – committed to continuous personal and professional developmentMust have a detailed understanding of the relevant medical device regulations for which audits reviews are being undertakenHas working knowledge of English language and language required for local clientsAdditional Information#LI-Onsite#J-18808-Ljbffr