Quality Assurance Manager - Ripon, United Kingdom - Real Staffing

Real Staffing

Verified Company

Ripon, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Our client is a Medical Device company with over 20 years' experience of design and manufacture of medical device products based in Yorkshire.

They work with surgeons, operating theatres and suppliers and their quality assured products are used in over 72countries and are sold under world renowned brands.

The Quality Assurance Manager will be responsible for managing the company's Quality Management System (QMS) in compliance with the requirements of ISO13485, EU MDD and MDR and UK Regulations.

Responsibilities:

The Quality Assurance Manager will be responsible for the management and improvement of key Quality Systems including but not limited to:

Complaints
CAPA
Non-Conformance
Internal audit programme
Training systems

Ownership of customer complaints and quality issues
Ownership of CAPA system
Management of the internal and external non-conformance process
The Quality Assurance Manager will lead internal audits to ISO 13485 and 21 CFR Part 820. Responsible for overseeing the effective completion of annual internal audit programme
Provides induction and refresher QMS training and other training on quality systems as required.
Help to maintain an effective company-wide training programme
Together with the Senior Quality Manager, lead audits by customers and notified bodies
Look at the continual improvement and compliance in relation to all quality practices
Manage quality related improvement projects e.g. implementation of electronic systems
The Quality Assurance Manager will present at management review presentations
Compile and monitor quality system and product quality metrics
Ensure support for production in the effective resolution of quality related issues
Support the calibration and maintenance system to ensure ongoing compliance
Support Purchasing in supplier approval, raw material acceptance, in-process control and batch release activity to meet production and delivery schedules
Review change control system to ensure timely closure

Qualifications

Ideally knowledge of medical device quality systems
ISO 13485 and related regulations
QA or RA in a highly regulated manufacturing environment

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales