Medical Device Specialist

Company Description

SGS 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.

Job Description

• 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 standards.
• Assist in business development as required and provide specific technical support to expand the company’s capability to offer valued services to customers.
• Conduct audits (either desk-based or on client’s sites) in accordance with established procedures and approved plans, maintaining a high standard of service delivery
• Ensure 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 expectations
• Provide accurate and timely reporting as required by line management to assist the planning and management of operations
• Ensure effective follow-up and timely close-out of non-conformities in accordance with established procedures
• Manage personal schedule to work efficiently and to meet target changeability requirements as defined by the Operations Manager
• Project-manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards
• Undertake 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 knowledge
• If required, to provide technical support and staff training to all parts of the business to enhance the service capability of the business
• Support 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 business
• Maintain a full knowledge and understanding of SGS procedures and external approval criteria to allow efficient and effective technical reviews

Qualifications

• University or technical college degree in one of the following:
• biology or microbiology
• chemistry or biochemistry
• computer and software technology
• electrical, electronic, mechanical engineering or bioengineering
• human physiology
• medicine
• pharmacy
• physics or biophysics
• 4 years of professional experience in relevant field
• Relevant industry such as: medical device industry and subcontractors, in vitro diagnostic industry and subcontractors, Sterilization department or sterilization service provider
• Appropriate knowledge of conformity assessment procedures laid down in medical device regulation 2017/745, FDA, SFDA.
• Appropriate knowledge of medical devices quality management system ISO 13485:2016 and must hold IRCA approved ISO 13485:2016 lead auditor certification.
• Demonstrate 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 & MDS1010,
• Knowledge of the 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 devices.
• Knowledge of clinical evaluations of product categories covered by regulation (EU) 2017/ 2185 codes
• Knowledge of relevant products standards covered by the regulation (EU) 2017/ 2185 codes
• Must be able to demonstrate and excellent working knowledge of medical device management and regulatory systems, standards, and compliance/auditing techniques
• Effective interpersonal skills; able to develop good working relationships with people at all levels
• Willingness to learn and adapt to change – committed to continuous personal and professional development
• Must have a detailed understanding of the relevant medical device regulations for which audits reviews are being undertaken

Additional Information

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