Senior Quality Innovation Engineer

  Bedford
  Full-time
  Salary dependent on experience
  Permanent

 

About the Client

Our client is a leading supplier of home pregnancy and fertility/ovulation tests. They are on a mission to empower women on their reproductive journey by offering innovative and reliable products.

 

 

About the Role

As a Senior Quality Innovation Engineer, you will be responsible for quality management processes and providing input for software design and development.

 

 

Responsibilities include:

QMS

  • Maintaining awareness of changes to regulations, standards and directives that affect the QMS specifically in regard to innovation and assisting with programmes to integrate new requirements into the QMS.
  • Managing and monitoring QMS Key Performance Indicators (KPIs) in relation to innovation.
  • Supporting Document Management through review, approval and improvement including key project documentation.
  • Providing support for external audit activities.
  • Championing and identifying improvements across the business in conjunction with stakeholders including innovation management systems.
  • Performing other appropriate unspecific duties related to the maintenance of the QMS as directed by the Quality Systems Manager.
  • Owning and leading the Risk Management process.

Innovation

  • Leading compliance for innovation and the implementation of existing products in new markets.
  • Identifying key technical challenges and offering recommendations.
  • Participating in risk analysis.
  • Supporting the improvement and maintenance of the organisation’s design control processes including design lifecycle.
  • Supporting the creation of project documentation to maintain compliance.
  • Contributing, where applicable, to technical reviews of designs, documentation and test procedures and any other deliverables.
  • Identifying any discrepancies in project compliance, addressing them through appropriate channels whilst supporting the implementation of corrective actions alongside the project teams.
  • Assisting with the implementation of new Design Control tools and their integration in the appropriate quality procedures.
  • Ensuring compliant onboarding of all companies where devices are third party sourced.

General

  • Being a dynamic team player who can work effectively and proactively on cross functional teams assisting with ensuring that the client maintains continued compliance.
  • Being self-motivated and working independently with all R&D project teams including project leaders and technical specialists.

 

Requirements:

Essential:
  • 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.
  • Experience of design and development in the medical devices industry.
  • A passion for quality.
  • Excellent communication skills.
  • An ability to build strong working relationships.
  • Be self-motivated and able to plan and manage own workload.
Preferred:

Some knowledge/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.
Desired 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

 

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