Senior Quality Engineer

IDE8 Ltd

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Senior Quality Engineer

Location: Inverness, IV1 3XF
Salary: £35k – 45k, DOE + Benefits
Contract: Full Time, Permanent


  • Competitive salary,
  • Flexible Working hours,
  • Private medical insurance,
  • long-term career prospects.

We have an exciting opportunity for a Senior Quality Engineer to join our team in our Inverness campus office.

Providing quality engineering support in designing new quality processes and product and process improvement support within a wide range of quality management systems in the industry.

Working across the medical device sector, you will get the opportunity to work with market leaders, innovators & start-ups, all with a single focus on developing products that save people’s lives.

The role will be to carry out quality system and quality assurance support internally and externally with our clients.

Senior Quality Engineer – The Role:

This is a key position that will include the following primary responsibilities:

  • Design quality assurance support across multiple projects, giving guidance and direction internally and externally.
  • Create effective and efficient project quality system documentation including, SOP’s, Work instructions & risk assessments.
  • Conduct multiple gap analyses for system improvements to MDR and IVDR.
  • Manage continuous improvement projects using appropriate tools.
  • Working with internal and external technical teams in the delivery of risk assessments in accordance with ISO 14971.
  • Create and manage Design History Files, Device Master Records and technical files for CE marking.

Senior Quality Engineer – The Candidate:

Skills and Qualifications required:

  • Degree/equivalent in a scientific discipline.
  • 5 years’ Quality engineering experience in a medical device, diagnostic or related regulated industry.
  • In-depth knowledge and experience managing compliance within ISO 13485:2016, ISO 14971, and FDA 21CFR part 820.
  • Working knowledge of Microsoft Windows Software: – Word, Excel, Access and PowerPoint.
  • Excellent analytical capability and independent problem-solving ability.
  • Ability to work independently as well as part of an interdisciplinary team.
  • Technical experience gained in an R&D laboratory setting.
  • Working Knowledge of Risk Management tools e.g., FMEA; SRA; DOE
  • Excellent Motivational and Influencing approach with strong communication skills
  • Ability to work in a fast-paced, deadline-driven, high impact environment
  • Excellent organizational skills, efficient and detail-oriented for working on multiple projects.
  • Ability to travel


  • Document Control admin Experience of using online Quality Management tools (e.g., MasterContol, OnePlm, TrackWise)
  • Process/Design Excellence Green Belt certified
  • Continuous improvement project experience
  • Design Verification & Validation experience
  • Mentoring/coaching experience, either formally or informally achieved.

If you have the required skills and experience, click on APPLY and forward an up-to-date CV and covering letter, with current salary details, explaining why you are a good fit for this role.

No Agencies please.

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