Medical Device Lead Auditors - USA (America).
Salary: 85-105K USD.
Location: Anywhere USA.
Main Purpose of Role:
• To plan and conduct professional management system audits in accordance with 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
• To carry out specific project tasks in relation to medical devices procedures, processes, systems and documentation.
• Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery.
• Conduct Technical Files review specific for products being authorized for
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested.
• If required undertake reviews of packs and make certification decisions within target timescales.
• Project-manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards
• Undertake personal professional development and ensure appropriate training records and personal logs are updated.
• If required, to provide technical support and staff training to all parts of the business in the USA and overseas to enhance the service capability of the business
• Must be able to demonstrate and excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
• Must be able to demonstrate a good knowledge of
• Electro-medical devices (active devices); and/or sterilization and non active devices
• Good experience with EN ISO 60601-1 3rd Edition and relative amendment; and/or Harmonised sterilization and cleanroom and on active medical device standards.
• Good experience with Risk Management EN ISO 14971:2012
• Good knowledge of ISO 13485, MDD 93/42/EEC and their application
• Good knowledge of Usability / Software standards such as 60601-1-6, 62366, 62304 and/or clean room and sterilization product standards.
• Registered lead auditor, or equivalent registration under other recognised body (Desirable on entry, Essential within one year)
SGS / IRCA / LRQA / UL / TUV / BSI / INTERTEK / DEKRA / LNE / BV / BUREAU VERITAS / 9001 / 9000 / 60601 / 60602 / ACTIVE DEVICES / ELECTRICAL / ELECTRONICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO MECHANICAL / ELECTRO MEDICAL / LEAD AUDTITOR / ASSESSOR / TECHNICAL FILES / TECHNICAL REVIEWER / PROJECT ENGINEER / PROJECT MANAGER / QA / QUALITY ASSURANCE / ISO 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / PRODUCTION / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / HEALTHCARE /MEDICAL / ENGINEERING / TECHNOLOGY / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / INFUSION / BOSTON SCIENTIFIC / DRUG DELIVERY / IVD / MDD / COMBINATION DEVICES / FORMULATIONS / PHARMA / PHARMACEUTICAL / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / CARDIOVASCUALR / NEUROVASCULAR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / US / USA / AMERICA / EU / EUROPE / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / BARD / MEDTRONIC / KARL STORZ / BBRAUN / ST JUDE / MEDTRONIC / LOMBARD MEDICAL / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / PHILLIPS / SWEDEN / AUSTRIA / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / OLYMPUS / ALLERGAN / DIAGNOSTICS / CAREFUSION / SIEMENS / TUV / SGS / BBRAUN / SORIN / ELEKTA / CE MARKING / CERTIFICATION / KITE MARK / BBRAUN / BIOMET / BIOTRONIK / BRISTOL MYERS / CONVATEC / COOPERVISION / COLOPLAST / QSERVE / CORIN / COVIDIEN / ELI LILLY / HOSPIRA / JOHNSON JOHNSON / J&J / PFIZER / ASTRA ZENECA / GSK / GLAXO / SMITHKLINE / LEICA / STRYKER / BECTON DICKINSON / MEDIMMUNE / MERCK / MYLAN / PHILIPS / CONSULTANT / CONSULTANCY / ROCHE / SAI GLOBAL / SAUFLON / SMITH NEPHEW / DEPUY / Florida, Texas, New York,Texas, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, San Diego, New Jersey, Houston, San jose, Milwaukee, Detroit, oregan, atlanta, maryland, vermont, hampshire, massachusetts, philadelphia, Denver, Minneapolis, Utah,Carolina, Virginia, Pennsylvania, Ohio, Carolina, Toronto, San Francisco, Los Angeles, Utah, Nevada, Idaho, Montana, Nebraska, Dakota, Las Vegas, Washington, Chicago, Iowa, Indiana, Pennsylvania, New Jersey, Connecticut, Missisippi, Houstan, Texas, Alabama, Louisianan, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, Santa monica, Long Beach, Newport Beach, Irvine, Anaheim, simi valley, Ontario, Thousand Oaks, San Clemente, Oxnard, Santa Barbara, Palmdale, San Bernadino, Hesperia, Apple Valley, Orange County, Compton, Manhattan Beach, Santa Ana, Santa Rosa, San Jose, Sacramento, Fremont, Alameda, El Granada, San Francisco, Emeryville, Colma, Millbrae, Belmont, san diego, California, Virginia, Pennsylvania, Ohio, Carolina, Toronto, San Francisco, Los Angeles, Utah, Nevada, Idaho, Montana, Nebraska, Dakota, Las Vegas, Oregan, Washington, Chicago, Iowa, Indiana, Michigan, New York, Toronto, Pennsylvania, Kentucky, New Jersey, Connecticut, Missisippi, tucson, el paso, Texas, Alabama, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, San Diego, New Jersey, San Diego, Louisiana, Houston, San jose, Milwaukee, Detroit, oregan, atlanta, maryland, vermont, hampshire, massachusetts, philadelphia, denver
- Medical Devices
- Certified Lead Auditor
- ISO 13485
- Quality Management Systems
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