Medical Device Quality Assurance Specialist

1 month ago


WS Clayhanger Walsall, United Kingdom CV-Library Full time
Job Overview:

Are you a quality engineer looking for your next role in the medical device industry? This opportunity is ideal for someone with experience in supplier quality assurance, incoming inspection of components/parts, and customer returned goods. The successful candidate will be based in Walsall and work closely with the production team to ensure that parts delivered from suppliers meet design specifications and quality requirements.

Salary and Benefits:
The estimated annual salary for this role is £40,000-£50,000, depending on experience, plus benefits such as 23 days holiday, bank holidays, insights bonus scheme, cycle to work scheme, and life insurance. As a full-time permanent employee, you will also enjoy a competitive pension scheme and opportunities for professional development.

Key Responsibilities:
This role involves working with the production team to ensure that all incoming parts/components meet quality standards, conducting supplier quality assessments, and ensuring the document control process is followed effectively. You will also play a key role in ensuring the CAPA and complaints process are adhered to, including gatekeeping for all incoming parts/components, monitoring open NCR/CAPA's, and change control management. Additionally, you will assist with risk management of medical devices and supplier quality assurance development.

Required Skills and Qualifications:
To succeed in this role, you will need experience working in the medical device industry as a quality engineer, a working knowledge of ISO 13485 and ISO 14971, and experience working with manufacturing/production in quality control. Knowledge of processes for transition from EU MDD to EU MDR is an advantage but not essential.

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