Medical Device Specialist

Main purpose of the role

• To 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
• To assist in business development as required and to provide specific technical support to expand the Companys capability to offer valued services to customers

Key Accountabilities

• Conduct audits (either desk-based or on clients 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
• To maintain a full knowledge and understanding of SGS procedures and external approval criteria to allow efficient and effective technical reviews

Qualifications :

Skills & Knowledge

Education:

• University or technical college degree in relevant sciences

1. biology or microbiology
2. chemistry or biochemistry
3. computer and software technology
4. electrical electronic mechanical engineering or bioengineering
5. human physiology
6. medicine
7. pharmacy
8. 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
• Must be IT literate i.e. competent in the use of MS Office applications and preferable experience of using large and complex databases
• 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
• Has working knowledge of English language and Language required for Local clients

Additional Information :

#LI-Onsite

Remote Work :

No

Employment Type :

Full-time