Contact us 0117 3182447

Quality Manager

£40,000 - £50,000+

Friday 29 Nov 2019

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3d Metal Printing is hiring a Quality Manager, to define and own the quality strategy that will take our Medtech product through design, regulatory approval and then to market.
 
This is an opportunity to manage quality for a novel custom-made, implantable, Class IIb product that will benefit mobility, health and quality of life for patients of all demographics worldwide.
 
An innovative startup, we combine additive manufacturing and digital technologies to create personalised medical devices, surgical planning software, VR and AR tools for surgeons. TOKA, an integrated technology product, is our most advanced medical device, with clinical trials due to start in 2020 in the UK and Europe.
 
Collaborating with our senior management, our quality officer, and our engineers, your expertise in quality management systems and medical device regulations is pivotal to achieving our ambitions.
 
Now is a great time to join the team as we build and validate our product, achieving the comprehensive approach to quality management that you aspire to.
 
Early deliverables
  • Understand and implement applicable regulations
  • Conceive and set TOKA's quality strategy, encompassing production and supply chain
  • Build upon our existing QMS
  • Establish the quality function and promote a culture of best practice
  • Apply for, and maintain, approval of ISO, CE, MDR standards for our device
  • Preparation for IEC approval of software components
We're looking for
  • Able to plan, organise and operate a rigorous approach to quality
  • Experience in quality management for Medtech or a medical device
  • Knowledge of ISO:13485, ISO:14971, FDA standards and certification processes
  • Familiarity with guiding on quality for new product development
  • Data accuracy, and familiarity with a modern QMS and MS Office
  • A self-motivated inclusive approach, from someone who works well with others
  • Considering quality management jobs in Bath - or commutable from Bristol - such as: Quality Manager | Quality Assurance Manager | Medical Device Quality Manager | Quality & Regulatory Manager etc.
You may also bring - or like to gain - knowledge around any of
  • Software validation process; IEC:62304
  • MDR and MDSAP
Salary and benefits include
  • £40,000 - £50,000+ we're keeping an open mind
  • Discretionary company bonus 
  • Discretionary relocation assistance - tell us what you need
  • Flexible working practices - including optional part time or partial remote working - tell us what you need
  • A role where you can build upon your strengths, with sponsorship toward further and professional qualifications 
About us
 
TOKA is a collaborative project between 3D Metal Printing and the University of Bath at the forefront of the digital healthcare revolution. Using additive manufacturing and digital technologies, we're transforming orthopaedic surgery to improve the quality of life for people affected by knee osteoarthritis - 4.5m people in the UK alone. Clinical trials begin Feb 2020 and product release Q4 - 2020. We're funded and have bright prospects. We're growing fast and looking forward to meeting our new colleague who can help us achieve our goals. https://www.toka.uk
 
Location: University of Bath Innovation Centre - by Bath Spa station - or partially remote
 
Timing: you may join us right away, or January to March - please engage now for firm commitment
 
Even if your CV isn't ready, please talk with Andrew at techfolk to find out more:
 
0117 318 2447 | hello[at]techfolk.co.uk | [at]we_are_techfolk
 
RECRUITERS: TOKA has selected techfolk as our selected recruitment partner for this position and cold calling and speculative applications are not welcomed.