Training & Competence Specialist
Key purpose of the role
This role has accountability to support the operation of the business by providing competence and training support, in accordance with the documented processes used by the Notified Body, ISO 17021 accreditation and EU Medical Device Directives and Regulations.
• Devising and providing training programmes globally for medical auditors, technical documentation assessors, clinicians, independent reviewers and certification authority to meet the requirements of the Notified Body.
• Qualification of new medical auditors, technical documentation assessors, independent reviewers and certification authority to meet the requirements of the Notified Body.
• Maintenance of qualification and NBOG coding for medical auditors and technical documentation assessors including specific code maintenance, witness audits
• Maintenance of qualification for independent reviewers and certification authority.
• Management and maintenance of administration staff competence.
• Co-ordination of public medical training programmes.
• Co-ordination of CPD in support of the Clinical team.
• Devise and deliver KPIs related to the training and competence programme.
• Maintenance of documented procedures related to the training and competence programme.
• Global co-ordination with Inter Offices to ensure training programmes are aligned.
• Liaising with departmental managers to understand and determine training needs and to develop these into tangible training plans.
• Evaluator of competency for medical auditors and technical documentation assessors globally.
• Development of training materials related to training and competence
• Co-ordination and support for Subject Matter Experts in relation to the development and delivery of training materials and training programmes.
• Escalation of training /competence related issues to the Quality Manager
• The role holder should possess either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors
• Has preferably at least 3 years’ experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories
• Have a good knowledge the EU Medical Device Directives and Regulations and Quality Management Systems
• Has a keen eye for detail and is focussed on delivering results within agreed timeframes
• Operates ethically with the highest degree of professional integrity
• Experience of working in a high pressure environment with constantly changing priorities
• Fluent in English and Swedish, written and spoken.
For more information about the position, please contact Erik Düring at +46 708 999469 or email@example.com