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Junior QA Officer (Medical Engineering)

Career Smart Consulting Ltd

Aston Clinton

On-site

GBP 25,000 - 35,000

5 days ago
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Job summary

An exciting opportunity awaits a quality assurance enthusiast to join a dynamic medical engineering firm. This role is perfect for a recent STEM graduate or someone with a few years of experience looking to dive into regulatory affairs. You'll be part of a small, dedicated team focused on ensuring compliance for innovative medical devices. Your contributions will directly impact the certification of cutting-edge surgical tools and systems. If you're eager to grow within a supportive environment and make a difference in healthcare technology, this position is tailored for you.

Benefits

Monthly paid bonuses

25 days holiday plus bank holidays

Pension scheme

Training and progression

Qualifications

  • Graduate in a relevant STEM field or 1-3 years of experience in QA.
  • Knowledge of MDR and FDA compliance is essential.

Responsibilities

  • Aid in compliance certifications for new medical products.
  • File technical documentation for MDR/FDA regulations.

Skills

Regulatory Affairs

Communication Skills

Team Player

Education

Degree in STEM field

Tools

MDR Compliance

FDA Compliance

Job description

Junior Quality Assurance (QA) Officer (Medical Devices)

Salary: £25,000 - £35,000 per annum

Benefits include: Monthly paid bonuses, 25 days holiday (plus bank holidays), pension scheme, training and progression.

Location: Aston Clinton (Aylesbury), Buckinghamshire.

Junior QA Officer Overview

This is a great opportunity for a quality assurance specialist / junior to join a growing medical engineering business based in Buckinghamshire. The company is a small part of a larger 300 employee business. The group designs and manufactures leading-edge electro-surgical tools, alongside the creative development of future surgical systems.

The business is looking for either a graduate in a STEM field looking to move into regulatory affairs and quality assurance, or someone with 1-3 years of commercial experience. The regulatory affairs specialist will need to come from an engineering background, ideally medical devices, as opposed to a drug development / pharma background.

You will join a small RA/QA team, comprised of two other RA/QA specialists. You will aid in the compliance certifications of new products, file technical documentation for MDR/FDA regulations and be involved in biocompatibility reports, clinical evaluations, risk assessments and post-market surveillance (and more!).

Junior QA Officer Requirements

  1. Degree qualified within a relevant STEM field.
  2. Experience in regulatory affairs is desirable, specifically on medical devices or similar.
  3. 0 - 3 years of commercial experience.
  4. Knowledge of MDR and FDA compliance.
  5. A good team player with excellent communication skills.
  6. A desire to join a high-performing team within a growing organisation.

If you are interested in discussing this quality assurance / QA officer position, please apply now and we'll be in touch.
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