Medical Devices Regulation

7 months ago

مصر, Egypt SGS Full time

Company Description
**We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 97,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.**

**Job Description**:
**Main Purpose of 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 Company’s capability to offer valued services to customers

**Main Purpose of 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 Company’s capability to offer valued services to customers

**Key Accountabilities**
- 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
- Complete all chargeable work within the required budget and timeframe to ensure customer satisfaction and efficiency of the business
- 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 manage personal expenditure required to fulfil the role aligned with local SGS policies in order that customer relations and profitability of the business are not compromised
- To maintain a full knowledge and understanding of SGS procedures and external approval criteria to allow efficient and effective technical reviews.
- At all times adopt a safe and professional behavior by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures
- Ensure full compliance with the Company’s Code of Integrity and Secrecy and Non-Disclosure Agreement

**Qualifications**:

- Shall have post-secondary education in one or several of the following technical areas: biology or microbiology, chemistry or biochemistry, computer and software technology, electrical, electronic, mechanical or bioengineering, human physiology, medicine, pharmacy, physics or biophysics etc
- A minimum of four years of full-time work experience is required, in the field of medical devices or related sectors (e.g. industry, healthcare, audit or research in medical devices or related area).
- 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
- Has working knowledge of English language and Language required for Local clients
- Approved ISO 13485 auditor or lead auditor with another CB
- Successfully pass ISO 13485 and/or ISO 9001 Lead Auditor courses

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