Overview
Austin Vita has a fantastic opportunity for a Quality Specialist to join a well reputed Medical Device company where you can expect to work on a life saving product. This is a hybrid role and will suit someone with strong Quality Assurance and CAPA experience.
Our client is a successful Medical device company providing innovative technology that makes a difference to people's lives. This role is focused on The Resuscitation division which delivers lifesaving equipment to hospital, military public safety department customers globally.
The Role
You'll be driving Quality Improvements through the CAPA program in a cross functional environment. Supporting Internal Audits and participating in external audits to ensure we maintain regulatory compliance.
- Monitor CAPA and Quality related KPIs to ensure targets are being achieved
- Maintain and improve the CAPA
- Ability to lead a cross- functional team through CAPA
- Participate in external audits related to manufacturing site under QMS
- Assisting in the review of Health Risk Assessments
- Assist in the development and review of Competent Authority, Registrar, and Regulatory Agency correspondence.
- Being the face of the UK Quality Assurance
Requirements
- 3-5 years of experience in a Quality Assurance role in Medical Devices
- A good understanding of ISO 13485, CAPAs, FDA QSR, MDD / MDR.
- Extensive experience & involvement in Internal & External Audits
- Experience of working face to face with MHRA
- Able to travel to UK Customer Sites.
Benefits
- Achievable 10% bonus on top of salary, based on company performance
- Hybrid working model (3 days in the office)
- Opportunity to explore other departments within the company
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
Austin Vita is acting as an Employment Agency in relation to this vacancy.
Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.