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 https://www.arrotek.com
We are currently recruiting for the position of Quality Engineer.
The responsibilities for this position will include the following:
- Assist with the development and maintenance of quality evaluation and control plans and protocols for processing materials into finished products.
- Assist with the confirmation that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.
- Issue of Product paperwork/lot records to manufacture and also review and release of same and compile COA/COC.
- Review and approval of Material Specifications and control of such.
- Approval of change requests for product, process and quality changes.
- Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects and change notices.
- Preparing and updating Operations procedures and associated documentation.
- Performing an active role in further development and continuous improvement of the QMS.
- Liaise with suppliers and customers on quality related issues.
- Assist Head of Quality in implementing and maintaining the QMS.
- Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions.
- Create, maintain and issue company quality documentation, such as SOP’s, and WI’s.
- Support customer and surveillance accredited audits.
- Drive continuous improvement and best practices in QMS “Right First Time”.
- Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.
- Updates job knowledge by participating in educational opportunities.
- Ensure compliance to all applicable regulatory standards and cGMP procedures and practices.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position by their manager.