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Job titleQARAC Sustaining Engineering Manager
Job typeMeditech
Salary60,000 - 65,000 GBP Yearly
LocationUK North
Bonus Package
Job description

We are currently recruiting for a market-leading therapeutics company who are looking for a Sustaining Engineering Manager with a bias on post-launch projects.    

The company 

Our client are a global medical and technologies company who manufacture and market innovative medical products focused on therapies for the management of chronic conditions. They work across four markets – advanced chronic and acute wound care, ostomy care, continence and critical care and infusion devices used in the treatment of diabetes and other conditions. 

The role 

This is a brilliant opportunity to protect, maintain and improve a portfolio of advanced wound care products on a global scale. In this role you will manage and provide strategic and technical direction to a team that deliver projects and maintenance as part of the business strategy. The role will also have a key responsibility for Quality, Regulatory and Clinical resources; ensuring that current products are maintained from a product quality and regulatory compliance perspective, whilst building strong relationships with customers, suppliers, stakeholders and support groups worldwide.

Main responsibilities include: 

  • Manage performance and development of product quality engineers, manufacturing engineers and regulatory affairs and clinical affairs associates
  • Lead post-launch maintenance activities related to product quality, regulatory compliance, and supply continuity
  • Ensure compliance to and technical rigor of the quality management system processes as they relate to change projects
  • Thinking of new ideas/strategies to drive transformation in the business unit 

The requirements 

A successful track record in sustaining engineering alongside experience of medical devices would  be advantageous alongside;

  • Experience of leading effective quality engineering / control operation
  • Knowledge and experience of implementing GxP and relative standards for manufacturing environments
  • Experience of working with relative regulatory requirements (QSR Part 820, ISO 13485, MDD 93/42, ISO 9001, GMP Parts 201 and 211)
  • Project management expertise including managing multiple tasks across multiple projects
  • A proven track record of delivery excellence through relevant processes, systems and technologies
  • Relevant academic background (ideally BSc or above in an Engineering or Scientific discipline)

Important information 

FMC Contact for this role: Natasha Szombara (

Reference number: 8624

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Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.