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QA Manager

4 months ago

Sittingbourne, United Kingdom Abbott Full time

Abbott Nutrition develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active.


We are recruiting for the position of Quality Assurance Manager, to be responsible for leading the QA Team and complaint handling for medical nutrition products and devices for the UK and Irish affiliates of Abbott Nutrition (AN) and providing QA guidance and support. Based in our Sittingbourne office and reporting into the Regional EMEA Commercial QA Manager, you will also be the Responsible Person for MHRA, supporting our obligations within the MDR.

What you’ll do:

Lead the QA team, supporting the growth and development of direct reports Responsible for ensuring that device and nutritional complaint investigations have been carried out in accordance with divisional and local procedures within the documented timeframe Responsible for the provision of QA training, development of departmental SOPs Review and interpret divisional policies ensuring local procedures are implemented and are compliant to requirements Communicate regulatory and customer requirements throughout the organisation Be the QA Management Representative with responsibility for the QMS Manage internal and external audit schedules and processes, as well as undertaking external supplier audits and associated quality plans Supports the AN Commercial function in areas such as clinical trials, contracts, and supports training of operational personnel in areas of GxP Timely reporting of complaints and adverse events and supporting in the event of product recall

What you’ll need:

Degree in a technical/engineering subject or life sciences Prior experience within a QA engineering/regulatory environment, ideally medical devices, with QMS experience Registered Lead/Internal Auditor to ISO9001 (experience of also auditing to ISO13485 ideal) Thorough understanding of QAM, GDP, GMP, ISO9001 and ISO13485 Prior people management experience Excellent communication skills, organisational skills and strong attention to detail Ability to analyse and interpret numerical data Member of Professional Institute (Chartered Quality Institute preferred)

At Abbott, you can have a good job that can grow into a great career. 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.