Jobs

Senior Quality Engineer- Innovation - Permanent - Bedfordshire

Quality
Ref: 467 Date Posted: Friday 10 Sep 2021
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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 innovation and assists with programmes to integrate new requirements into the QMS
  • Management and monitoring of QMS Key Performance Indicators (KPIs) in relation to Innovation
  • Supports Document Management through timely 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 Innovation management Systems
  • Perform other appropriate unspecific duties related to Quality Management as directed by the Quality Director.
  • Owns & leads the Risk Management process.

Innovation

  • Leads compliance for Innovation & the implementation of existing product into new markets
  • Identify key technical challenges and offer recommendations
  • Participation in risk analysis
  • Support the improvement & maintenance of the organisation’s design control processes including design lifecycle.
  • Support creation of project documentation to maintain compliance
  • Contribute, where applicable, to technical reviews of designs, documentation & 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.
  • To assist with the implementation of new Design Control tools and their integration in the appropriate Quality procedures
  • Ensures compliant onboarding of all companies where devices are 3rd Party sourced

Contacts

  • The role holder is a dynamic team player who can work effectively and proactively on cross functional teams assisting with ensuring that SPD 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.

Person Specification

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 Devises Industry 
  • Passion for quality
  • Excellent communication skills
  • An ability to build strong working relationships
  • Be self-motivated and able to plan and manage own workload

Desirable

  • 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

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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