Location: East Anglia
An exciting opportunity has arisen for a fast-growing Biotechnology organization based in the Cambridge area.
The Quality Manager will be responsible for ensuring that the business operates to the highest quality standards. Defining and implementing the quality systems and procedures to ensure full compliance with the appropriate standards (ISO 13485:2016).
The individual will ensure finished product is quality controlled to meet specifications and quality standards.
Responsibilities & Duties:
- Maintaining an effective Quality Management System (QMS) and implementing continuous improvement.
- Ensuring that manufacturing or production processes meet the required standards.
- Supporting audits, internal and external inspections.
- Conducting supplier/customer audits where required.
- Carrying out procedural reviews to ensure most effective processes are adopted
- Assisting with any Quality related issues and reasonable requests
- Provision guidance and support on ISO13485 requirements
- Conducting and support of internal and external non-conformance investigations using industry standard methods for root cause analysis and identification of corrective and preventive actions (CAPA), including monitoring of quality trends
The Quality Manager will be educated to BSc in Science or Engineering with at least 2 years’ experience of managing CAPA and related investigations and validation experience.
The Quality Manager will be expected to have experience in working with multi-disciplinary teams, and getting things done with external partners.
The successful candidate will have:
Strong analytical/problem solving skills
Good communication (written & verbal) & strong presentation skills
Skills: ISO13485 QMS, Computer, ISO 14971 and 17025 standards,
Maintain quality certifications, Biotechnology industry, Validation, Manufacturing.
To apply for this position, candidates must be eligible to live and work in the UK