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- Posted on 5th February 2019

Quality Assurance Manager

Location: Oxford, UK

Contract: Permanent

Hours: Full Time

Travel: Occasionally required (UK & International) e.g. partner sites, other company offices

Salary:  £40K+ (depending on experience) + Benefits

Description & Requirements

Mirada builds cutting-edge software for the medical imaging world, helping doctors diagnose and treat cancer. Based in Oxford, we are a small, dynamic team of skilled people who love to build software.

The QA/RA department supports the company at a corporate level and regionally in both the UK and the US. With the support of the Executive Management Team and Board of Directors, the QA/RA department supports the company to meet quality standards and objectives in all areas of the business.

The QA Manager reports to the Head of Regulatory Affairs and has responsibility for:

  • The maintenance and continuous improvement of the QMS in accordance with quality standards and guidelines
  • QA planning and budgeting

Interested? Get in touch and tell us what you can bring in terms of strengths, skills and enthusiasm to enhance our expanding team.

Essential Skills and Behaviours

  • 5 years + commercial QA experience in a medical device environment
  • Experience of managing external audits from notified bodies
  • Detailed knowledge of ISO 13485:2016
  • Excellent written and verbal communication skills at all levels
  • Performing internal and supplier audits
  • Experience of establishing company quality objectives
  • CAPA management

 

Advantageous Skills and Behaviours

  • 3 years + commercial experience as a QA Manager in a medical device environment
  • knowledge of ISO 14971, IEC 62304, IEC 62366, MDSAP, MDD, MDR, US CFR 21 Part 820 (CGMP)
  • Knowledge/experience of software development lifecycles
  • Line management experience

About Mirada Medical

Mirada is a prominent global brand in medical imaging software based in Oxford. Our innovative software solutions are routinely used in imaging centres and cancer centres worldwide.

Our team includes some of the world’s most talented professionals. We encourage innovation and creativity and we are very proud to provide a supportive and motivational environment.

Company Culture

Mirada Medical values staff as the company’s greatest asset.  Our objective is to deliver exceptional products and service to our customers; we recognise that every member of Mirada helps make this possible. Diversity and individuality are celebrated qualities in our workplace. Innovation and inspiration are encouraged and supported with autonomy and teamwork.

Available Benefits

  • 25 days annual leave plus 8 paid bank holidays and extra leave based on length of service
  • Performance based bonus
  • 3% company contribution-matching pension
  • Flexible working opportunities
  • Opportunity to buy or sell annual leave
  • Cycle to Work scheme
  • Childcare vouchers
  • Refreshments provided