Arrotek Medical is a medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. We strive to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package.
For further information on Arrotek Medical, visit http://www.arrotek.com
We are currently recruiting for the position of Quality Engineer.
The responsibilities for this position will include the following:
- Provide technical quality support to Project Manager, Design Engineers,
- Production manager and clients.
- Work closely with Engineering team and the client to establish and maintain compliant product specifications.
- Quality review of process validation plan, protocols, and reports.
- Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.
- Issue, review, and release of lot records to manufacturing.
- Co-ordinate and review of testing and release of sterilise product.
- Quality review of SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures.
- Review and approve product change controls.
- Liaise with suppliers and clients on quality related issues.
- Perform an active role in the maintenance, further development and continuous improvement of the QMS.
- Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints.
- Perform CAPA reports.
- Support clients in product submission to applicable regulatory authorities.
- Conduct internal audits and compilation of associated documentation.
- Support and assist in the preparation for customer and surveillance audits.
- Updates job knowledge by participating in educational opportunities.
- Other such duties as may be assigned from time to time by their manager
The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.