Quality Assurance Officer

4 weeks ago

London, United Kingdom TEC PARTNERS LIMITED Full time

My client, a high growth, next generation med tech company who have developed several ground-breaking technologies which address global needs for high throughput laboratory and remote testing. This is an exciting opportunity for a talented Quality AssuranceOfficer to play a pivotal role in the business helping to further my client's Quality Management Systems as they inch closer to having their ground breaking devices on the market.

Quality Assurance Officer

As Quality Assurance Officer, you will take responsibility for the maintenance and improvements to the standing Quality Management Systems ensuring compliance in line with current regulations. You will also support companywide training ensuring all QA activitiesare adhered to throughout the business while assisting with validation activities, change controls, non-conformances, root cause analysis, and Corrective and Preventative actions.

Quality Assurance Officer Responsibilities:

- Support effective management of compliance with ISO 13485:2016
- Writing, reviewing, releasing and distributing Quality System documents
- Responsible for various database maintenance
- Plan and conduct internal audits
- Supporting with supplier quality management process
- Promote QA activities, ensuring excellent relationships throughout the business
- Receiving in coming goods, checking and recording them on the database
- Monitoring and maintaining stock levels
- Managing CAPA's, NCR's, KPI's, and validation activities

Quality Assurance Officer Requirements:

- 2 years' experience of working with Quality Management Systems / ISO certification maintenance
- Familiarity with ISO 13485, FDA, IVDR and GMP/GLP
- Experience working in process driven environment
- Strong organisational and communication skills
- Experience writing QA documents and Standard Operating Procedures
- Experience of performing internal audits
- Experience of managing deviations, non-conformances and CAPS's

This opportunity will allow a driven Quality Assurance Officer to develop in a fast paced and challenging setting as my client continue to grow. You will be an integral part of the team giving guidance throughout the business in a Quality capacity in readinessof both products hitting the market. On offer are further development opportunities and competitive salary options.

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