Job Details

Senior Quality Specialist - Risk Management

Stirling, Stirling, United Kingdom, £48,000 , Permanent

Posted: 20days ago


Senior Quality Engineer - Risk Management

Based in Stirling, some flexibility - preference on site

SRG partner with a leading medical technology, boasting exceptional growth in the diagnostics arena. With major operations in both the UK and US, they pioneer the development, manufacturing and marketing of diagnostic care solutions.
Following the launch of a new platform, they require a Senior Quality Engineer to hold responsibility for Quality and Regulatory actions associated with IVD assays and QC controls.

* Managing Risk Management activities, both pre and post market - ensuring that procedures followed are in compliance with ISO 14971
* Application of risk management to medical devices
* Work with project teams to support in the design and development process for products throughout the development lifecycle
* Quality and regulatory activities associated with IVD assays
* Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases
* Management of post marketing surveillance in line with risk management activities Support the transfer of product from R&D to manufacture
* Support the creation of the technical files for CE marking
* Internal audits, NCs, CAPAs
* Work with individual assay development teams as a quality and regulatory support
* Work with the Technical Leaders and Project Managers to maintain quality throughout the Design and Development process

Skills and Experience
* Experience of working to quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
* Experience of Risk Management in an IVD or Medical Device environment
* Experience of working in an IVD or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.
* Experience of pre and post launch IVD or medical device activities
* Scientific background.
* Excellent organizational skills for working on multiple projects.
* Ability to use problem solving tools and methodologies.
* Influence internal project team and external parties to maximize success opportunities
* CE marking and other global regulatory submissions

Please contact me: (url removed) or (phone number removed) for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena

Job Details

Stirling, Stirling, United Kingdom