Austin Vita has been engaged exclusively by a leading global contract development and manufacturing business within the Medical Devices Sector. We are recruiting for the latest addition to the quality team, a Snr Quality Engineer – Concept NPI/Programmes.

Role Purpose:

* To ensure the New Product Introduction System continues to be compliant with external standards and regulations
* To ensure that NPI products are guided through the NPI system and are transferred into operations effectively
* To liaise with other functional areas, including Regulatory Affairs, Innovation & Product Development to ensure the correct start & input stages of projects
* Act as a role model for the Quality Assurance & Regulatory function, leading by example

Key Accountabilities:

* To identify, define and manage deliverables for validation and risk management activities within the NPI programmes to ensure product compliance
* To interface with all levels of the business, customers, suppliers & regulatory bodies
* To identify & drive continuous improvement through the lifecycle management of the products
* To write & approve documents required for the MDF/DHF Technical File, as well as protocols & reports for NPI stages
* To check protocols & reports including human factors, 10993 testing etc
* Supplier control and management for Design & Development stages

Minimum Requirements:

* Educated to degree level or equivalent in relevant subject
* Proven experience in a similar role within Quality Engineering – gained either in a Quality or NPI environment
* Knowledge of design control
* Working knowledge of statistical tools including Mini Tab, Dof E, R&R and capability indices
* Good working knowledge of ISO 13485, 21 CRF Part 820, ISO 14971, ISO 10993, GMP (Orange Guide) European MDR, QSIT

If this role is of interest to you and you meet all of the minimum requirements then please apply and I will be in touch

Snr QA Engineer (NPI) – Up to £45,000 – Norfolk

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.