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 https://www.linkedin.com/company/arrotek-medical-ltd/.
We are currently recruiting for the position of Quality Technician.
Responsibilities:
The responsibilities for this position will include the following:
· Issue batch records for manufacturing.
· Review and release of manufacturing batch records.
· Support review and approve of change controls.
· Work closely with quality engineering team and the client to establish and maintain compliant product specifications.
· Perform an active role in the maintenance and continuous improvement of the QMS.
· Support quality engineers with non-conformance & customer complaints (root cause analysis, disposition, and corrective action).
· Conduct internal audits and compilation of associated documentation.
· Assist the Quality Engineer with new product introduction.
· Support and assist in the preparation for customer and surveillance audits.
· Support with the review and generation of quality metrics.
· Liaise with suppliers and clients on quality related issues.
· Review documentation for completeness and compliance to QMS.
· Responsible for scanning, filing, backing up and archiving quality documentation to maintain Arrotek’s quality management system.
· Maintain and control all external supplied documentation which may affect product realisation.
· Update job knowledge by participating in educational opportunities.
· Other such duties as may be assigned from time to time by their Manager/Supervisor.
Person Specification:
Candidates likely to be called for interview will have most or all of the following:
· Minimum 2 years’ Medical Device assembly experience.
· Proficient computer skills.
· Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
· Internal auditing experience would be an advantage.
· Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required, and ability to multitask and prioritise.
· Good interpersonal skills and organisational skills.
· Excellent attention to detail.
· Excellent written and verbal communication skills, with the ability to communicate appropriately with different departments, suppliers and customers.
· Self-motivated, flexible with a desire to learn new tasks.
· Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives.
· Excellent MS Office experience (Word, Excel, PowerPoint etc.).
· High level of teamwork and engagement.
Position Details
This is a full-time position on a Permanent contract with a view to starting as soon as possible.
Applications:
Interested applicants should submit their up to date CV and Cover Letter to [email protected]. All applications will be treated in strict confidence.
Arrotek Medical is an equal opportunities employer.
