IVD Lead Auditor - Home Based, Germany - €60-€77k
Context / Dimensions
The scope of the position will typically cover clients within the your native country primarily as well as EMEA. The role is home-based.
Key responsibilities and accountabilities
- Ensure that value is added to customers and their business/organisation through the assessment of their systems and processes against requirements
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with company policy, procedures and prescribed time frame.
- Continually enhance & uphold the reputation and perception of the client through excellent planning, delivery, report writing and day-to-day interactions with customers and other key stakeholders
- Demonstrate commercial acumen and real added value when feeding back to clients
- Continually demonstrate a professional and engaging approach whilst assessing clients
Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and enhance appropriate professional qualification status in relevant disciplines
- Be an active member of the Service Delivery Team and proactively engage with peers and key stakeholders to ensure continual improvement, in line with the standards of Assessor Excellence.
- Proven industry experience/knowledge/qualifications related to medical devices
- Demonstrates knowledge of how a business operates to ensure appropriate interpretation of management system standards.
- Excellent presentation skills, able to present assessment findings professionally and effectively, often through formal stand-up presentation to a group of senior managers and Directors.
- Energy and commitment to undertake the role, which can be very demanding, working within different premises every day, being in front of the client and constantly on the move.
- Engaging & highly skilled communicator, able to convey clear messages in a compelling and coherent way
- Ability to produce high quality professional reports at a reasonable pace, explaining technical issues and demonstrating added value.
- Proven administrative and organisational skills, with the ability to meet deadlines and manage customer expectations
- Strong emotional intelligence with the ability to adapt style to a variety of situations
- Effective relationship builder through a personable, consultative approach
- Computer literate with experience of basic microsoft packages
- Travel within the UK and the ability to spend nights away from home
- Advocate of continuous professional development with the learning ability to keep up with changes to business, industry, management thinking and developing assessment styles.
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 /
- Medical Devices
- Certified Lead Auditor
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