About Beckman Coulter Diagnostics
For over 80 years, we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward.
We value diversity, inclusion, and individuality, creating a culture where everyone can thrive.
You will be part of a team that develops strong relationships with other departments and works together to achieve common goals.
Job Description
The Quality Engineer role is responsible for ensuring Quality Project deliverables are achieved and coordinating the creation, review, and approval of non-conformance documents, equipment change controls, and manufacturing documentation.
This position provides Quality expertise during investigations and daily manufacturing issues, driving process improvements and ensuring compliance with Good Manufacturing Practices and Quality Systems Regulations.
The successful candidate will be part of the R&D QA Team and report to the Blood Virus Quality Manager.
Responsibilities
* Support the New Product Development Process, specifically Patient Sample Manufacture within BCII.
* Ensure compliance to Quality and Regulatory Standards in Non-conformance processes (NCs).
* Create, review, and approve Equipment and Manufacturing documentation.
* Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs).
* Review and approval/release of Batch History Records.
* Analyze and report meaningful quality metrics to ensure on-going improvement programmes are put in place.
* Represent Quality at both internal and external audits.
Requirements
* Bachelor's degree (Honours Level 8) in chemistry, biochemistry, biology, or other relevant technical field.
* Minimum 0-2 years experience in a highly regulated (FDA desirable) healthcare or related environment.
* Strong team player with the ability to identify and drive quality improvements.
* Ability to work independently.
* Excellent planning and organisational skills.
* Candidates must possess the following skills: Quality Engineering, CAPA, NC, QA, Quality Assurance.
Benefits
* Pension
* Medical Aid / Health Care
* Performance Bonus