About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
The Opportunity
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We are recruiting for a Quality Assurance Specialist to join the team. This position works out of our Sittingbourne location in the Nutrition division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
As the Quality Assurance Specialist , you’ll support the QA Manager and the team in complaint handling for medical nutrition products and devices for the UK and Irish affiliates of Abbott Nutrition (AN) and support to ensure compliance with Abbott Laboratories Ltd. policies and procedures.
What You’ll Do
Support the QA Department:
- takes responsibility to see that device and nutritional complaint investigations have been carried out in accordance with divisional and local procedures within the documented timeframe.
- promotes a culture of continuous improvement
- takes responsibility for the provision of QA training, as required
- reviews and interprets divisional policies ensuring that local procedures are implemented and are compliant to divisional / regulatory requirements
- communicates regulatory and customer requirements throughout the organisation.
Operates as the QA Management Representative with responsibility for the AN UK Quality Management System (QMS).
Manages the internal and external audit schedules and processes.
Undertakes external supplier audits, creates / reviews technical agreements and quality plans between AN UK and their suppliers.
Contracts, and supports Training of Operational personnel in areas of GxP. Support complaint handling, follow up on Complaints investigations and closure Assists the AN Commercial QA manager in leading the UK AN commercial affiliate in the event of a product recall.
- Accountable for overall compliance of the QMS for AN within the UK and Irish affiliates.
- Timely reporting of complaints and adverse events.
- Producing departmental reports and KPI calculations.
- Developing and maintaining departmental SOPs.
- Following relevant Abbott policies and procedures / local regulations.
- Continual review and improvement of the QMS and quality related activities within the AN UK and Irish affiliates.
Required Qualifications
- Degree (BSc or equivalent) in a technical / engineering subject, or life sciences.
- Knowledge and experience gained within a QA Engineering / regulatory environment.
- Experience with ISO9001 (experience of auditing to ISO13485 preferred).
- Thorough understanding of QAM, GDP, GMP, ISO9001 and ISO13485.
- QMS experience in medical devices preferred (to ISO13485).
- Excellent written and verbal communication skills.
- Excellent organisational skills and strong attention to detail.
- Competent use of Microsoft Office.
- Ability to analyse and interpret numerical data.
- Evidence of CPD in a QA / regulatory environment.
WHAT WE OFFER
As you’d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.
