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Medical Device Auditor, Korea South

게시됨 2024-07-05
만료 2024-08-05
ID #2227204496
Free
Medical Device Auditor, Korea South
Korea South, 서울, 서울,
게시됨 July 5, 2024

설명

Our people are ambitious and humble, believing in what they do and convinced that our purpose is shaping a world of trust. With responsibility and openness, they daily serve our 400.000 clients in 140 countries, to bettering society.

Across all our businesses and countries, each one of our people leaves their mark in shaping society.> We believe that leaving a mark is a true challenge and opportunity for every one of us.

> We believe that leaving a mark is a sign of trust and impact.

> We believe that leaving a mark is a bond with the future.

> We believe that leaving a mark is proof of growth and development.

Being part of the BV family, is more than just working, it’s being convinced that you will leave your mark...

in shaping a world of Trust.

Business Duties Supports the audit delivery in medical device Sector (ISO 13485, MDD/MDR CE Marking) Supports the process of obtaining and maintaining the relevant approvals/accreditations.

Develops procedures for product delivery, which satisfy appropriate requirements, (.

accreditation requirements) Helps define criteria for the control and development of the Competences Centres, which deliver the product.

Provides product support to the network and/or coordinate projects related to product development.

Maintains an in-depth knowledge of the product and related standards and requirements, in order to provide credible and efficient support.

Promotes existing products/services.

Provides trainings to technical requirements and details MDR requirements.

Regularly meets clients, competitors and stakeholders, to understand and summarize clients’ needs and anticipate evolutions.

Cooperates on the definition & implementation of global marketing initiatives.

Supports the accreditations activities of BVC worldwide and performs any other activities, as instructed by their line manager.

People Development Lead through example by tireless learning Engage with Team member and create “One Team” culture Acquire talents from various channel to enhance existing service and to expand service scope Provide with necessary/relevant training to potential talent to enhance capability and upgrade job skillset and contribute to drive result Develop successor plan to narrow down the position vacancy and smooth transition Organize efficient team with right position with its clear role & responsibility Report Report to BU Manager and dotted line report to Region and GBL Qualification: Major: Technical scientific master’s degree (.: bioengineering, clinical engineering, chemistry, biology, computer science, electrical engineering, electronics, mechanics, physics, medicine, pharmacy, biotechnology, engineering, mathematics, natural sciences) 4 years of professional experience in the field of health care products or related activities, such as manufacturing, research or auditing; of them 2 years of experience in the design, manufacture, testing or professional use of the medical devices or technology to be assessed or in fields connected with the technical-scientific aspects to be assessed.

In the event that the experience was acquired only with activities carried out in a CAB, at least five FT assessments are required in the previous two years also in relation to Directive 93/42.

Working Experience accepted as follows; - design, research and development, manufacture, quality control and regulation in the field of health products or - Study of the technology of a medical device and its application; or - performing tests on a medical device in accordance with national or international standard or - performing performance tests, clinical evaluation or clinical testing of a medical device.

or - Continuing activity for at least 3 years of auditing in a definite manufacturing technology for MDs or - technical support activities for the examination of audit reports and for the development of schema documents - for at least two continuous years - at the certification / notified body for medical devices or accredited by ISO 13485 In-depth knowledge and Completion of course Directive 93/42/EEC , REG (EU) 2017/745 and of related binding legislation and knowledge of other guidelines related with Directive 93/42/EEC , REG (EU) 2017/745 Successful completion of specific course (40 hours for ISO 9001; upgrade course for ISO 13485) Completion of course related with risk management (rif.

ISO 14971) Completion of course the principles of clinical evaluation Join an inclusive, flexible and diverse company where you can thrive while contributing to positively transforming the world we live in.

#Shapinga Worldof Trust #leaveyourmark

작업 세부 정보:

직업 종류: 풀 타임
계약 유형: 영구적인
급여 유형: 월간 간행물
직업: Medical device auditor

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