Our client is a rapidly growing medical device manufacturer who has a newly created position.
55K plus 15% bonus.
You will be working within a similar role for a medical device/healthcare/pharmaceutical organisation and have the following skills;
* Proficient in quality systems (ISO 13485), associated documentation
* Proficient medical device industry experience
* Bachelor’s degree in a related field
* Minimum 5 years’ experience working in Quality roles within Medical devices.
Purpose of Role
All applicants must have experience in ISO 13485
* Manages and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
* Accountable for all Quality requirements for the business
* Accountability for monitoring and maintenance of existing processes
* Accountable for internal and external audits
* Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
* Accountable for the execution of Notified Body audits and track progress of responses
* Accountable for investigating quality issues and interact with products suppliers regarding these
* Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
* Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
* Authorising product release to stock and completion of relevant records upon receipt
* Ensures effective planning and tracking of activities.
* Ensures effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance.
* Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements.
* Clearly defines and communicates regulatory strategy in support of new product registration, in line with commercial objectives.
* Develops proposals for initiatives and implements, as required
Corrective And Preventive Action (Capa)