Senior Quality Engineer - Software - Permanent - Bedfordshire

Ref: 466 Date Posted: Wednesday 05 Jan 2022
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Purpose of role

The role works within an In-Vitro Diagnostic Quality Management System (QMS) and complies to the requirements:

  • ISO 13485
  • Council Directive 98/79/EC
  • In-Vitro Diagnostic Medical Device Regulation 2017/746
  • US FDA 21 CFR Part 820
  • Other worldwide regulatory and compliance standards

Main Responsibilities

  • QMS
  • Maintains awareness of changes to regulations, standards and directives that affect the QMS specifically software and assists with programmes to integrate new requirements into the QMS
  • Management and monitoring of QMS Key Performance Indicators (KPIs) in relation to software
  • Supports Document Management through review, approval and improvement including key project documentation
  • Provides support for external audit activities
  • Champions and identifies improvements across the business in conjunction with stakeholders including software management
  • Perform other appropriate unspecific duties related to the maintenance of the QMS as directed by the Quality Systems Manager.

Software Product Development

  • Contribute & provide input for software design & development project teams to support and advise on all aspects of compliance with design control requirements
  • Identify key technical challenges and offer recommendations
  • Participation in software risk analysis
  • Support the improvement & maintenance of the organisation’s design control processes including the software design lifecycle.
  • Support creation of software specific documentation to maintain compliance
  • Contribute, where applicable, to software technical reviews of software designs, coding, documentation & test procedures and any other software deliverables.
  • Ensure software version control system is compliant
  • Ensure defect tracking systems (e.g. JIRA) remain compliant.
  • Identifying any discrepancies in project compliance and addressing them through appropriate channels and support the implementation of corrective actions alongside the project teams.
  • To assist with the implementation of new software tools and their integration in the appropriate Quality procedures


  • The role holder is a dynamic team player who can work effectively and proactively on cross functional teams assisting with ensuring that the client maintains continued compliance.
  • This self-motivated individual will be required to work independently and with all R&D project teams, including Project Leaders and technical specialists.
  • The role holder will work closely with the Software team.

Person Specification


  • Degree or equivalent or 3+ years’ experience of working within a medical device environment.
  • Knowledge of ISO 13485:2016 and US FDA 21 CFR 820
  • Passion for quality
  • Excellent communication skills
  • An ability to build strong working relationships
  • Be self-motivated and able to plan and manage own workload


  • Ideally would have some knowledge &/or experience in the following: -
  • EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC
  • Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746
  • Medical Device Single Audit Program (MDSAP)
  • Member of the Chartered Quality Institute
  • ISO 62304 Medical device software — Software life cycle processes
  • BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
  • Knowledge or experience of software including the development of applications using Microsoft technologies 
  • Ability to understand & learn new software development, processes, languages, tools and systems

Personal Attributes

  • Takes ownership and accountability
  • Focusses on priorities and overcomes challenges
  • Makes timely and effective decisions
  • Drives compliance as a competitive advantage
  • Builds trust and respect in relationships
  • Is inclusive and collaborated to deliver results
  • Communicates persuasively to gain commitment
  • Understands and adapts to their audience

Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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