Description
- Direct the application of the Quality System requirements for determining that components and finished goods comply with established specifications, standards and regulations (i.e., MDD, FDA, ISO, HealthCanada).
- Manage quality assurance activities for the advancement of the business through application of advanced quality systems and concepts.
- Responsible for the development, implementation review and analysis of QA documentation such as (but not limited to) CAPA and non-conformance files, complaint management, change requests, validation protocols and reports, etc.
- Responsible for ensuring all environmental and product monitoring requirements are met.
- Responsible for ensuring required sterilization validations and routine monitoring is completed.
- Assures adequate sampling plans, inspection procedures and test methods are implemented.
- Develop and maintain quality audit programs; Support and respond to all customer audit requests, Manage all regulatory audits
- Management review compliance
- Creates and implements quality improvement programs.
- Creates and maintains quality indicators and respective reports/ presentations.
- Responsible for the development and training of QA employees.
- Responsible for maintaining Quality budget.
- Responsible for attending monthly management review meetings and maintaining a close working relationship with the management team on site.#
Essential Requirements;
- Previous experience of working within the medical device industry - ESSENTIAL
- Previous experience of working within a Quality Assurance role at a similar level - ESSENTIAL
- Previous experience of working to ISO13485 - ESSENTIAL
- Previous experience of working to MDD requirements - ESSENTIAL
- Previous experience of working to FDA requirements - DESIRABLE
There is flexibility for some working at home for this role, they operate flexitime around working hours.
They are also offering a relocation package and a healthy £55-58,000 starting salary.
They are looking to move on this ASAP so if you believe you have the correct experience then please forward me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com