Description:
The successful candidate will form part of an established Quality team and report to the Quality Manager. At this moment we are looking for someone who can cover a period of 12 months contract.
Essential duties and responsibilities include:
- Assist the Quality Manager in implementing and maintaining the quality management system.
- Ensure that requirements laid down in the Quality Manual and Standard Operating Procedures and any other company quality documents are adhered to, and provide advice and guidance on quality related aspects.
- Conduct internal audits, including closing out audit findings in a timely manner, creating audits finding reports and determine proper corrective and preventive actions.
- Lead supplier quality related activities
- Create, maintain and issue company quality documentation, such as standard operating procedures.
- Member of New Product Introduction team, with responsibilities that include generating quality documentation.
- Generation and management of process deviations, non-conformances, supplier complaints, re-works, CAPA, complaints, rejects and change notices.
- Works with Production to solve in-house quality concerns, reviews of non-conforming product and recommends disposition.
- It will be also needed to regularly monitor a specific production area to ensure product is manufactured and sterilised as per the relevant quality documentation.
- Liaise with sterilisation sub-contractor for routine sterilisation activities and associated product testing.
Qualifications
- Degree in Quality/ Science or Engineering.
- Experience in a Quality role within a similar manufacturing organization is an advantage.
- Knowledge of and experience with ISO 13485, FDA regulations Part 820 and the Medical. Device Directive (93/42/EEC) would be an advantage.
- Working experience of EO and gamma sterilization processes with knowledge of the associated standards (ISO 11135 & ISO 11137) would be an advantage