Medical Devices Auditor

3 weeks 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.

Plan and conduct professional management system audits and training in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standard.
- Carry out the Audit and Training in compliance of requirements set in procedures, instructions, and other necessary documentations.
- Ensure that audit dates and duration of audit have been agreed with the client and that audits are carried out in a timely manner.
- Prepare Audit report in line procedural requirements, including classification of all/any non-conformities and submit it to the technical coordinator for review process.
- Coordination with all audit team members to agree a final recommendation, consistent with audit findings, including classification of all/any non-conformities.
- Follow-up of non-conformities, or re-audit where necessary, to ensure that they are closed out in line with SGS procedural requirements, using appropriate, competent audit team members where necessary.

**Qualifications** Qualifications**
- University or technical college degree in relevant sciences
- Relevant sciences such as: Biomedical engineering, Health technology, Mechanical engineering, Electronical engineering.
- 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
- 2 years of the 4 of relevant professional experience shall be in quality management
- Relevant functions in quality processes related to MD such as: Quality engineer/manager, CAPA or complaint engineer / manager

**Essential**
- Appropriate knowledge of conformity assessment procedures laid down in medical device regulation 2017/745.
- 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/MDA codes per Regulation (EU) 2017/ 2185 codes and 4 years of industrial working experience knowledge specifically for MDS 1004, MDS1009, MDS1010,
- knowledge of the standards such as cleanroom ISO 14644 series, biological evaluation ISO 10993 series, clinical investigation ISO 14155, risk management of medical devices ISO 14971 associated with the product covered by the MDA codes per regulation (EU) 2017/ 2185)
- Knowledge of MEDDEV 2.1/5 Medical devices with measuring function, IEC 62366-1 Medical devices—Application of usability engineering to medical devices
- Knowledge of IEC62304 Medical device software - Software life cycle processes either by intensive use or by training
- Knowledge of IEC/ISO 60601 - requirements for design of electrical and electromechanical medical devices to ensure safety and essential performance
- Knowledge of Directive 2006/42/EC either by intensive use or by training
- Appropriate knowledge of devices legislation as well as related harmonized standards, Common specifications (CS) and guidance documents
- knowledge on MDCG documents for medical devices.
- Knowledge of clinical evaluations for product categories covered by codes MDA per regulation (EU) 2017/ 2185.
- 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**
- Excellent working knowledge of management systems, standards and compliance/auditing techniques
- Effective interpersonal skills; able to develop good working relationships with people at all levels
- Computer literacy, excellent communication, and presentation skills
- Technical knowledge and experience in related field and in using management methods and tools.

**Additional Benefits**:

- Social Insurance
- Medical & Life Insurance (Employee & Spouse)
- Annual Bonus

  • Medical Devices Regulation

    3 weeks 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...

  • Medical Device Territory Sales Manager

    1 month ago

    مصر, Egypt Accumedic systems Full time

    Our company is on the hunt for a talented and experienced Territory sales manager in the field of dermatology and Aesthetic surgery. We are looking for a self-motivated professional with proven experience and an outstanding track record in sales. In this position, you will be responsible for meeting our annual sales targets within assigned regions and...

  • Medical Device Territory Sales Manager

    1 week ago

    مصر, Egypt Accumedic systems Full time

    Our company is on the hunt for a talented and experienced Territory sales manager in the field of dermatology and Aesthetic surgery. We are looking for a self-motivated professional with proven experience and an outstanding track record in sales. In this position, you will be responsible for meeting our annual sales targets within the region of Cairo and...

  • Medical Sales Representative

    2 weeks ago

    مصر, Egypt Alafaf Medical Services Full time

    Job Post (Sales representatives) About AMS: AMS is an Egyptian company licensed by AMPM training (UK) to equip Egypt’s healthcare providers with pioneering, patient centric products, and services they need to improve the health of the population. Due to our expansion, we are seeking highly motivated **Sales Representatives.** **Job...

  • Medical Sales Support

    3 weeks ago

    مصر, Egypt Medical Departures Inc. Full time

    **About Us**: Medical Departures Inc. is the world leader in finding and booking global doctors & dentists with a network of +6000 clinics/hospitals & +10,000 doctors/dentists in 29 different countries. We are a fully remote company. The team is spread throughout Latin-America, Europe, Africa, and Asia. With more than 50 team members, the team forms a...

  • Rf Design Engineering

    2 weeks ago

    مصر, Egypt Analog Devices Full time

    Come join Analog Devices (ADI) - a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and...

  • Intern

    4 weeks ago

    مصر, Egypt Analog Devices Full time

    Come join Analog Devices (ADI) - a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and...

  • Senior Engineer, Analog Design Engineering

    4 weeks ago

    مصر, Egypt Analog Devices Full time

    Analog Devices (NASDAQ: ADI) designs and manufactures semiconductor products and solutions. We enable our customers to interpret the world around us by intelligently bridging the physical and digital worlds with unmatched technologies that sense, measure and connect. The senior IC design engineer will be responsible for Analog/mm-wave circuit design. Tasks...

  • Engineer, Analog Design Engineering

    2 weeks ago

    مصر, Egypt Analog Devices Full time

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Engineer, Digital Design Engineer

    4 weeks ago

    مصر, Egypt Analog Devices Full time

    Come join Analog Devices (ADI) - a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and...

  • Engineer, Design Evaluation Engineering

    2 weeks ago

    مصر, Egypt Analog Devices Full time

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Designer, Layout

    2 weeks ago

    مصر, Egypt Analog Devices Full time

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Engineer, Digital Design Engineering

    2 weeks ago

    مصر, Egypt Analog Devices Full time

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Engineer, PCB Layout Engineering

    2 weeks ago

    مصر, Egypt Analog Devices Full time

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Bio Medical Technicians

    3 weeks ago

    مصر, Egypt Staff Arabia Full time

    Excellent Pharmaceutical & Hearing Aids vacancies in KSA / only Egyptian nationality can apply Our client is a Pharmaceutical and medical equipment company specialized in the hearing aids field in Saudi Arabia, requires recruiting experienced & talented calibers to join the company to fulfill the following position **Bio Medical Technicians** - Diploma in...

  • Product Specialist

    7 days ago

    مصر, Egypt DMC For Medical Supplies Full time

    Summary DMC is a well-established medical supplies company and a sole agent for (Medtronic, Merit Medical Systems, and Molnlycke) with diversified scope in both distributing and marketing medical devices. DMC has +20 years of prominent existence in the local market. DMC Egypt is located in AlFostat City - Old Cairo and its HQ at Old Cairo as well. Vacancy:...

  • Information Security Management System

    3 weeks 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...

  • International Automotive Task Force

    3 weeks 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...

  • Hse Medical Coordinator

    3 weeks ago

    مصر, Egypt Subsea 7 Full time

    **Organisation** **Position** HSE Medical Coordinator **Vacancy ref** 83156 **Based in** Cairo **Business area** Subsea & Conventional **Contract type** Staff **Closing date** 24/07/2024 Vacancy information At Subsea 7, we take pride in being recognized globally as a leader across the Energy Industry. For 5 decades our people have delivered...

  • Sales Representative

    2 weeks ago

    مصر, Egypt Medical Departures Inc. Full time

    **About Us**: Medical Departures Inc. is the world leader in finding and booking global doctors & dentists with a network of +6000 clinics/hospitals & +10,000 doctors/dentists in 29 different countries. We are a fully remote company. The team is spread throughout Latin America, Europe, Africa, and Asia. With more than 50 team members, the team forms a...