QA Officer

Owlstone Medical s mission is to save 100,000 lives and $1.5 billion in healthcare costs. We want to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease.

As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. We are therefore looking for a QA Officer to support the Quality Team Lead with the compliance of our QMS - Currently ISO9001:2015, specifically for OML s diagnostics development.

Key Tasks / Accountabilities

Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes.

Work with the Program/Project/ Department Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint.

Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule.

Perform desk-based, remote and on-site audits of sub-contractors and suppliers.

Working with other QA staff, provide support to departments, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS.

Maintain thorough knowledge and understanding of ISO standards requirements, regulatory expectations and guidance documents relevant to the work performed within the program.

Support Quality department initiatives as required, as part of a multi-disciplinary team.

Requirements

Education and Training

Degree level qualification within Life Sciences (or equivalent)

Competencies / Requirements

Essential

Planning and Organising

Self-Motivated and able to work independently when required

Strong presentation, communication and influencing skills

Pragmatic with a flexible approach and the ability to deal with changing priorities

Ability to work in a dynamic environment

Experience and Knowledge

Suitable working knowledge within a Pharmaceutical/Medical Device QA department

Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards

Essential: ISO 9001,

Essential: ISO 13485, ISO17025

Desirable: experience of FDA regulations and ICH requirements

Desirable: experience of auditing Suppliers to ISO13485

Desirable: Regulatory experience including post market surveillance

Experience of an Electronic Document Management System

Experience of using an Electronic Quality Management System (ideally Q-Pulse)

Experience in using Excel and PowerPoint

Skills

Good inter-personal and communication skills

Good organisational and time management skills