The Quality Engineer helps to improve and maintain an integrated management system, ensuring that Perspectum’s products and services are fit for purpose, consistent, and meet both external and internal requirements. This includes supporting regulatory, legal compliance and customer expectations. They are pivotal in ensuring and managing the activities required to meet various quality standards, including ISO 13485, ISO 27001, ISO 9001, ISO 14971, IEC 62304 and 21 CFR Part 11 & Part 820.
- Establishing and maintaining Perspectum’s quality documentation
- Working with the Product Managers to review requirements and risks
- Ensuring that development processes meet international and national standards
- Monitoring quality performance by gathering relevant data and producing reports
- Driving continual improvements
- Training staff so that they fulfil the requirements of the integrated management system
- Plan and perform regular internal and supplier audits
- Assist during external audits
- Ensure that technical documentation is complete, conforming to the applicable standards
Skills and Requirements: Essential
- Experience performing internal audits
- Ability to work independently
- Ability to plan and manage your workload
- Ability to work to deadlines
- An aptitude for analysis
- Interpersonal skills and the ability to work as part of a team
- Ability to support employees from other teams on how to follow the processes prescribed by the integrated management system
- Good organisational skills, especially with documentation
Skills and Requirements: Desired
- Degree in Life Sciences or equivalent
- Lead Auditor training
- Experience performing 3rd party audits or acting as the Lead Auditor during internal audits
- Experience of medical device quality standards such as IEC 62304, ISO 13485 and ISO 14971
- Experience of information and cyber security standards
- Experience acting in a quality role
- Internal auditor training
Interested in this position?
We are always looking for brilliant people to join us here at Perspectum Diagnostics.
Use the form below to send us your application.