Software Quality Manager. Saffron Walden, Essex

Posted 6 February by XIST4 Recruitment Featured
Software Quality Manager (Regulated Environment, ISO 13485, ISO 15189)

Location: Saffron Walden, Essex

Salary: £45-50,000

Benefits include: Company Equity worth about £2,000 per year, 3-5% bonus, 10% Pension contribution, private medical insurance.

On offer is a unique opportunity to work within an environment that makes a real difference to people's lives.

Software Quality Manager - Key Skills:

- Degree in an engineering or science discipline.
- Strong leadership experience. Ability to build a small team of 2-3 testers.
- 5-7 years' experience in quality assurance field in a regulated environment.
- Quality Certification preferred e.g. CQE etc.
- Knowledge and experience applying quality regulations and standards (e.g. ISO 13485 and ISO 15189).
- Solid understanding of the application of ISO 14971 or IEC 62304.
- Experience with design controls, risk management, validation and change control.
- Experienced with failure investigations and failure report writing, trend analysis
- Must be eligible to work in the UK.

About the role:

As a Software Quality Manager you will provide leadership, guidance and over site of software development, testing and bioinformatics activities for our client's clinical laboratories.

Your role as a Software Quality Manager will involve:

- Quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products.

- Acting as Quality lead in relation to software design and development for medical laboratory implementation.

- Providing interpretation and guidance on quality standards, regulations and directives and develop procedures to ensure compliance.

About the Company:

Human Science and health has never been in better hands.

For more information on this Software Quality Manager role (Regulated Environment, ISO 13485, ISO 15189), please apply now for an interview.

Required skills

  • Management
  • Quality Assurance
  • Testing
  • Regulated Environment
  • CQE

Reference: 34405303

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