Quality Engineer Software Development
Share
Job Location:
Monthly Salary:
Posted on:
Vacancies:
Job Summary
QA Engineer Software Development
Oxford UK Hybrid
Oxford Nanopore Technologies (ONT) are global leaders in nanopore-based next generation sequencing technology developing innovative research and IVD products used worldwide.
Were looking for a QA Engineer Software Developmentto support design control activities across flow cells chemical components and reagent-based products ensuring compliant development through to production transfer.
The Role
Duties include but are not limited to:
- Support design planning requirements traceability and documentation review
- Oversee Verification & Validation (V&V) planning and execution
- Partner with R&D Technical Transfer Manufacturing and Regulatory Affairs
- Contribute to risk management activities
- Review and approve Design & Development and Change Control documentation
- Support CAPA non-conformance and Quality System processes
- Ensure compliance with ISO 9001 / ISO 13485 GMP GLP and GDP
You will have authority to review and approve D&D processes and records.
About You
Essential:
- BSc in Engineering or relevant Scientific discipline (or equivalent experience)
- 5 years experience in Design/Development or QA within an ISO 9001 / ISO 13485 regulated environment
- Strong understanding of design controls V&V risk management and traceability
- Experience with design and development of software and firmware products including software product lifecycle management.
- Working knowledge of DMS Change Control and CAPA systems
Desirable:
- Medical device or IVD experience
- Internal Auditor training (ISO 9001/13485)
- Validation experience (statistical process or CSV)
Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics worldwide.
Please note that no terminology in this advert is intended to discriminate on the grounds of a persons gender marital status race religion colour age disability or sexual orientation. Every candidate will be assessed only in accordance with their merits qualifications and abilities to perform the duties of the job.
#LI-LH1
#LI-hybrid
Required Experience:
IC
Key Skills
- Account Payable
- Apache Commons
- Community Support
- Corporate Risk Management
- Garment
- Java
About Company
Oxford Nanopore’s goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology enabling the real-time, high-performance, accessible and scalable analysis ... View more
