Medical Devices Lead Auditor (Non-Active Devices) - Permanent - Manchester
Job Title: Medical Devices Lead Auditor (Non-Active Devices) - Permanent - Manchester
Training: Comes with Globally Recognized Training and Lead Auditor/Expert Qualifications
Location: Home-Based, Anywhere in the West Midlands / Manchester
Type: Permanent, Full Time
Hours: 37.5 hours per week
Travel: Circa 50%
Salary: Circa €55k +Company Car
Benefits: 10% performance bonus, retail discount scheme, private health cover, contributory stakeholder pension scheme and life cover.
We have an excellent new opportunity for multiple Medical Devices Lead Auditors (Non-Active Devices) to join our global organisation.The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Conduct audits (desk-based or on client’s sites) in accordance with Medical Devices management systems standards ISO 13485.
- Maintain a high standard of service delivery that ensures effective customer relationships and ongoing business development.
- Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
- Ensure completion of all assigned work and relevant documentation in accordance with required procedures and standards to fulfil customer expectations.
- Provide accurate and timely reporting to assist the planning and management of operations.
- Support business development activities as required (including follow up and/or referral of enquiries, sales visits, assistance at events, seminars, etc) to enable on-going growth of the business.
- Manage personal schedule to work efficiently and to meet target chargeability requirements as defined by the Regional Manager.
- 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 to maintain relevant auditor registrations and relevant industry knowledge.
- If required, to provide technical support and staff training to all parts of the business in UK and overseas to enhance the service capability of the business.
Work experience in positions with significant QA, Regulatory or management systems responsibility.
- Knowledge corresponding to post-secondary education to equivalent work experience in one or several of the following areas: electronic, electrical, mechanical and software technology Medical devices.
- Successful completion of other formal qualification (advanced degrees) can substitute for a maximum of two years of working experience.
- Knowledge of Risk Management EN ISO 14971:2012.
- Knowledge of auditing against recognised standards.
- Able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
- Detailed understanding of the relevant medical device regulations for which audits are being undertaken.
- Excellent working knowledge of ISO 13485 and its application.
- Good knowledge of Design, manufacturing of medical devices, the technology involved and their intended uses.
- Knowledge of relevant product standards in the assessment of medical devices.
- Knowledge of risks associated with Medical Devices.
- Effective interpersonal skills; able to develop good working relationships with people at all levels.
- IT literate i.e. competent in the use of MS Office applications and preferably experience of using large and complex databases.
- Willingness to learn and adapt to change - committed to continuous personal and professional development.
- will be able demonstrate good manufacturing and technical knowledge of electro-medical devices and their relevant harmonized standards.
- Strong background in the medical device industry, and 4 years working experience in medical device related industry or activities.
- Knowledge of MDD 93/42/EEC and their application.
- Have worked for another notified body.
- Candidates who have a responsibility for an organisations ISO 13485 Quality Management System would be advantageous.
- In general, auditors shall have a minimum of four years of full-time work experience in the field of medical devices or related sectors (i.e medical devices industry, audit or research in medical devices.
- Able to demonstrate a good knowledge of sterilization and non-active devices.
- Knowledge of Legal Framework of regulations and role of the Certification Body.
- Experience with Harmonised sterilization, clean-room and non-active medical device standards.
- Experience in the operation of the relevant sterilization processes i.e. experience as a practising microbiologist in support of such sterilization processes.
- Relevant technical application of the sterilization validation processes
- Able to motivate and lead others in a 'project team’ environment.
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