Medical Devices Product Expert & Auditor – APAC
Type; Permanent.
Salary: Negotiable.
Location: Home/Office Based China or Japan.
Travel: Yes, 20%.
Purpose:
The Medical Team is geared towards worldwide certification of medical devices and quality systems.
The role:
An expert in testing and inspection, a company with a real passion for safeguarding quality and safety in the area’s of technology, mobility and environment. With a presence in over fifty countries they are one of the largest players in the industry.
Your tasks
- You are responsible for the assessment of technical files and the auditing of the quality system of your customers (from high innovative start-ups to large multinationals, both national and international)
- You act as a linchpin and maintain frequent contact with your customers, colleagues, external experts like physicians, contractors and authorities
- You will have the opportunity to represent the business at conferences
- The position entails travelling within and outside Europe, approximately 20-30% of the time
Your skills:
- Higher vocational or university level education, in life and/or engineering sciences.
- A minimum of 4 years of full time work experiences in medical device related industry, including at least 2 years in R&D, QA/RA.
- Experienced in at least one of the following devices categories and areas of expertise: soft tissue implants, cardiovascular devices, drug device combinations, animal tissue and IVD.
- Experience with quality management systems and relevant laws and regulations, at least CE.
- Project management and auditing experience is considered an advantage certification. We are part of the international assessment
APAC / PACIFIC OCEAN / EAST ASIA / SOUTH EAST ASIA / ASIA / HONG KONG / TAIWAN / SHANGHAI / KUALA LUMPUR / MEDAN / JAKARTA / CAMBODIA / SEMBILAN / TANJUNG / PINANG / MERSING / TAIPING / MALACCA / BRUNEI / MALAYSIA / INDONESIA / MAKASSAR / SARAWAK / KALIMANTAN / SABAH / SYDNEY / PERTH / ADELAIDE / BRISBANE / CANBERRA / BANGKOK / BURMA / MYANMAR / CHINA,BEIJING,SHENZHEN,WENZHOU,SHANGHAI,SHANDONG,HENAN,XIAN,SHAANXI,HUBEI,WUHAN,JIANGSU,NANJING,ANHUI,FUJIAN,ZHEJIANG,TAIWAN,GUANGDONG,HUBEI,HONG KONG,NANJING,ANHUI,WUHAN,HANGZHOU,CHONGQING,CHENGDU,CHINESE, Shanghai, Shenzhen, Nanjing, Jiangsu, Anhui, HANGZHOU, ZHEJIANG, BEIJING, SHANDONG, HENAN, WUHAN, CHINA, NAGOYA, TOKYO, JAPAN, CHIBA, SHIZUOKA, NAGANO, FUKUSHIMA, KANAZAWA, TOTTORI, OSAKA, TSU, HIROSHIMA, NAGASAKI, KUMAMOTO, AKITA, SENDAI, MATSUYAMA / MAKASSAR / MALUKU / VIETNAM / BANGKOK / LAOS / BURMA / MEDAN / HANOI / PATTAYA / TAIPEI / MANILA / NEPAL / SRI LANKA / COLOMBO / NEW DELHI / HYDERABAD / MUMBAI / DAVAO / CAMBODIA / China, India, Japan, Australia, Thailand, Indonesia, Vietnam, Singapore, Malaysia, Japan, Korea, Hong Kong / MINH CITY / LAOS / MANILA / KALUSUSNAN / PHILIPPINES / VISAYAS / NEGROS / MINDANAO / DAVAO / PALAU / PALAWAN / SABAH / BRUNEI / CHINA / JAPAN / IVD / ANNEX A / ANNEX B / IN VITRO DIAGNOSTICS / BLOOD GROUPING / REAGENTS / ABBOTT / ORGANON / GRIFFOLS / ABO SYSTEMS / RHESUS / ANTI KELL / DUFFY . HIV / BLOOD GROUPS / MOLECULAR BIOLOGY / ANTI DUFFY / ANTI KIDD / ANTIBODIES / CONGENITAL / RUBELLA / TOXOPLASMOSIS / HEREDITARY DISEASE / PHENYLKETUNORIA / HUMAN INFECTIONS / CHLAMYDIA / HLA TISSUE GROUPS / TUMORAL MARKER / TRISOMY / BLOOD SUGAR / CLINICAL CHEMISTRY / HAEMATOLOGY / IMMUNOLOGY / OVULATION / PREGNANCY / SPECIMEN / STERILES / MICROMECHANICS / BIOLOGICAL ACTIVE COATING / NANOMATERIALS . IN VITRO FERTILISATION / MEDICAL DEVICES / TESTING / TECHNICAL / CERTIFICATION / INSPECTION / CRO / CLINICAL TRIALS / CLINICAL RESEARCH / TUV / DEKRA / LRQA / SGS / SAI GLOBAL / CE MARKING / DNV / CERTIFICATION / NOTIFIED BODY / FDA / 21 CFR / TUV SUD / TUV NORD / INTERTEK / UL / QA / QUALITY ASSURANCE / 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / SOFTWARE / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / ELECTRO MEDICAL / ELECTRO-MECHANICAL / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / EUROPE / UK / UNITED KINGDOM / IVD / MEDICAL DIAGNOSTICS / IN VITRO DIAGNOSTICS / ENGLAND / EUROPE / RELOCATE / US / AMERICA / CALIFORNIA / GERMANY / FRANCE / VALIDATION / ASSAY DEVELOPMENT / BIOCHEMICAL / BIOMEDICAL / MICROBIOLOGY / PRODUCTION / MOLECULAR BIOLOGY / HIV / BLOOD / DIAGNOSTICS / RISK ASSESSMENT / RISK MANAGEMENT / TECHNICAL / UK / LONDON / OXFORDSHIRE / BUCKS / BUCKINGHAMSHIRE / CAMBRIDGE / CAMBRIDGESHIRE / NORTHAMPTON / BIRMINGHAM / WARWICK / WARWICKSHIRE / HERTS / HERTFORDSHIRE / FRANKFURT / LONDON / EUROPE / RELOCATE / BERLIN / PARIS / Amsterdam, Rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, Drachten, Leeuwarden, Groningen, assen, leiden / BELGIUM / FRANCE / GERMANY / CERTIFICATION / NOTIFIED BODY / SWEDEN . SWITZERLAND / MEDTRONIC / ST JUDE / CE MARKING / GMP / COMPLIANCE /
