Quality Assurance Specialist

20 hours ago


Walsall, Walsall, United Kingdom Quality Start Full time
Company Overview
Quality Start is a specialist recruitment consultancy that acts as a bridge between talented professionals and exciting job opportunities. With a focus on the medical device industry, we are dedicated to helping quality engineers take their careers to the next level.

Salary
An excellent salary awaits our successful candidate, based in Walsall, along with great benefits such as 23 days holidays plus bank holidays, Insights Bonus scheme, cycle to work scheme, Life insurance, and much more.

Job Description
As a Quality Engineer at Quality Start, you will be responsible for ensuring that parts delivered from suppliers meet design specifications and quality requirements. This involves working closely with the production team to conduct supplier quality assessments, including creating and following up on SCARs. Your key duties will include:
  • Gatekeeper for all incoming parts/components
  • Ensuring suppliers meet quality standards specified in supplier quality agreements
  • Creating Production Feedback Reports, NCRs, and CAPAs for product and process issues found in Production
  • Ensuring customer returns, document control, and complaint process adherence
  • NCR/CAPA – Root cause analysis, monitoring of open NCR/CAPAs
  • Change control – Monitoring of open change control, raising new change control
  • Document control
  • Risk Management of medical devices
  • Supplier quality assurance development

Required Skills and Qualifications
To succeed in this role, you must have experience working in a medical device industry as a quality engineer, along with a working knowledge of ISO 13485 and ISO 14971. Additionally, experience working with manufacturing/production in quality control is essential. Knowledge in processes for transition from EU MDD to EU MDR is a plus but not mandatory.

Benefits
This is a full-time permanent job opportunity that offers an excellent salary, great benefits, and a chance to grow your career in the medical device industry.

Others
If you're a motivated quality engineer looking for a new challenge, please don't hesitate to contact us. We look forward to hearing from you.

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