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The role is covered in the following locations: Newcastle-upon-Tyne

Role Overview

The Risk Management & Quality Officer is responsible for helping to maintain and improve the Product Risk Management Process and Quality Management System (QMS) by identifying improvements and efficiencies to develop, revise and implement Risk Management procedures and policies.

The Risk Management & Quality Officer will work with the QRA team to ensure products and design and development of future products are compliant with the requirements of IVDR, ISO 13485:2016, BS EN ISO 14971 and IEC 62304.

Key Duties and Responsibilities

Performing a combination, but not necessarily all, of the following duties:
o Maintain a positive attitude and assist the Product Risk Management Lead to ensure deliverables are achieved within target timelines.
o Champion the highest level of quality & process and undertake training in order to develop.
o Work with the Product Risk Management Lead to identify and implement process improvements and efficiencies.
o Manage individual projects and work packages as required.
o Communicate effectively with all teams and functions

Technical Delivery:
o Help to compile and maintain Risk Management Files for all products.
o Ensure consistency of Risk Management Files across products.
o Promote the benefits of the product risk management process to all employees.
o Research relevant Regulatory and Quality Standards updates including contributing to assessment for impact on Risk Management Files.
o Take an active role in researching and implementing a cybersecurity risk management process in compliance with relevant requirements, as dictated by company needs.
o Facilitate product risk management throughout the product lifecycle by liaising with internal teams to maintain risk assessments in accordance with risk management processes.
o Effectively interact with Technical, Development, Planning and Commercial teams to ensure research and development, production and post-production including post market surveillance is performed in in line with company procedures.
o Review instances of non-conformance, propose possible suitable corrections, corrective and preventive actions and assess the impact on risk management files for products.
Participate in vigilance-related risk management meetings and ensure focus on risk to patients and end-users is maintained.
o Participate in 3rd party audits as required.
o Prepare and maintain hazard and risk control verification trace matrices using Aligned Elements software.
o Support post-market data gathering and reporting in line with regulatory requirements and company Post Market Surveillance and Vigilance procedures, assessing impacts on product Risk Management Files
o Support design review and control of change processes with product risk management input.
o Work within the rest of the QRA team to maintain focused, effective progression in line with Company Quality objectives.
o Support other members of the Quality team by providing training and mentoring on areas of expertise.
o Effectively interact with Technical, Development and Planning teams to ensure research and development is performed in accordance with company procedures.
o Facilitate the continued work toward established goals, objectives, policies, procedures and systems pertaining to the QMS.
o Support the QRA team to ensure compliance with relevant national and international standards and legislation.
o Help to design and deliver training sessions to ensure the understanding and compliance of all employees.
o Attend external training events as required to ensure continuous professional development.
o Promote the benefits of the quality system to all employees.
o Perform other duties that may be required from time to time.

Person Specification

Experience, knowledge and requirements
o A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
o A minimum of 2 years' experience in working within a ISO 13485 compliant Quality Management System.
o Experience of IVD risk management processes including ISO 14971.
o Experience of medical device risk management processes under FDA requirements would be desirable.
o Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
o Good sense of humour and ability to adapt to a changing environment following recent commercial launch of flagship product.
o Ability to work full time within the UK without restriction.

26 Sep 2022

Maia D'Souza

Laboratory Recruiter 01494 818021

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